125 Cmc Jobs - Page 4

Christian Medical College is looking for Staff III Critical Care Therapist to join our dynamic team and embark on a rewarding career journey Assessment and Evaluation:Conduct comprehensive assessments of clients' emotional, psychological, and behavioral concerns Administer and interpret standardized assessment tools to gather relevant information Collaborate with clients to identify their strengths, challenges, and goals Analyze assessment results to determine appropriate therapeutic interventions Treatment Planning and Implementation:Develop individualized treatment plans based on clients' needs, goals, and diagnosis Select and implement evidence-based therapeutic interventions and techniques Provide counseling and therapy sessions using various modalities (eg, cognitive-behavioral therapy, psychodynamic therapy, family therapy) Facilitate individual, couples, family, or group therapy sessions as appropriate Monitor clients' progress and adjust treatment plans as necessary Counseling and Support:Create a safe and supportive environment for clients to express their thoughts and emotions Assist clients in identifying and understanding the root causes of their issues Help clients develop coping strategies and healthy behaviors to manage their challenges Provide guidance and support in decision-making and problem-solving processes Promote self-awareness, self-esteem, and personal growth in clients Documentation and Record-Keeping:Maintain accurate and confidential client records, including assessment results, treatment plans, progress notes, and discharge summaries Ensure compliance with legal, ethical, and regulatory requirements for client confidentiality and record-keeping Collaboration and Referrals:Collaborate with other healthcare professionals, such as psychiatrists, psychologists, or social workers, for comprehensive client care Provide referrals to specialized services or community resources when appropriate Consult with colleagues or supervisors regarding complex cases or ethical concerns Continuing Education and Professional Development:Stay updated with current research, best practices, and therapeutic approaches in the field Attend workshops, conferences, or training programs to enhance knowledge and skills Engage in supervision or consultation to receive guidance and support in professional growth Ethical and Professional Conduct:Adhere to ethical guidelines and professional standards set by relevant counseling or therapy associations Maintain professional boundaries and confidentiality in all interactions with clients Conduct oneself with empathy, compassion, and cultural sensitivity Qualification : B.Sc., Critical Care Technology (B.Sc., with One year Internship) from any recognized University or Diploma in Critical Care Therapy obtained from CMC Hospital (H.Sc., with two year Diploma with one year internship) and those who have completed 4 years of experience as Jr. Critical Care Therapist or equivalent only need to apply. Age Limit: Below 35 years Note: Only Regular mode will be accepted, Private or correspondence will be not accepted.

JOB DESCRIPTION Position : Manager/Senior Manager Job Location : Gurgaon Education : M. Pharm Department : Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems. Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills: Hands of expertise of preparation & review of dossiers, response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e. g. , manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Education Minimum Requirement: M-Pharm in pharmaceutical sciences Required Experience and Skills: 10-15 years of hands on experience in regulatory affairs This role needs a seasoned professional who is aware of the regulatory activities for NDAs, can work in R & D CFT and who has the management capability of leading a group of team members The candidate must be proficient in English; additional language skills are a plus. Good inter-personnel skills with ability to direct multi-departmental functions.

Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effective planning to organize installation activities in time. Coordination between engineering and quality for product issues. Timely resolution of Customer complaints. Development of Dealer Service capabilities for field service to end user to avoid load. Payment follow up for Service billings Basic Qualifications (Essential qualifications, language, driving licence etc) Bachelor of Engineering Mechanical with 6/7 year work experience. Travel Work Arrangements/Requirements Travel 70% time. Passport Required Key Competencies Absolute KEY skills needed for role Handon experience over repair of Big Rotary Machines or similar products Product knowledge of Liquid Ring Vacuum Pump and CF Blowers or big rotary machines. Humble and pleasant in nature Fluent in languages. SAP knowledge Negotiation skills for generating Service Revenue Lean on us to help you make life better We think and act like owners. We are committed to making our customers successful. We are bold in our aspirations while moving forward with humility and integrity. We foster inspired teams. Colorado Resident Bicycle rights prism poutine austin. Drinking vinegar gluten-free iceland, typewriter farm-to-table selfies XOXO food truck four loko. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request and a member of our team will contact you.

Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effective planning to organize installation activities in time. Coordination between engineering and quality for product issues. Timely resolution of Customer complaints. Development of Dealer Service capabilities for field service to end user to avoid load. Payment follow up for Service billings Basic Qualifications (Essential qualifications, language, driving licence etc) Bachelor of Engineering Mechanical with 6/7 year work experience. Travel Work Arrangements/Requirements Travel 70% time. Passport Required Key Competencies Absolute KEY skills needed for role Handon experience over repair of Big Rotary Machines or similar products Product knowledge of Liquid Ring Vacuum Pump and CF Blowers or big rotary machines. Humble and pleasant in nature Fluent in languages. SAP knowledge Negotiation skills for generating Service Revenue Special Accommodation If you are a person with a disability and need assistance applying for a job, please submit a request . Lean on us to help you make life better We think and act like owners. We are committed to making our customers successful. We are bold in our aspirations while moving forward with humility and integrity. We foster inspired teams. Colorado Resident Bicycle rights prism poutine austin. Drinking vinegar gluten-free iceland, typewriter farm-to-table selfies XOXO food truck four loko. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request and a member of our team will contact you.

Senior Service Engineer Job Details | Ingersoll Rand Careers Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Service Engineer Chennai, TN, IN, 603 002 Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division & part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effective planning to organize installation activities in time. Coordination between engineering and quality for product issues. Timely resolution of Customer complaints. Development of Dealer Service capabilities for field service to end user to avoid load. Payment follow up for Service billings Basic Qualifications (Essential qualifications, language, driving licence etc) Bachelor of Engineering Mechanical with 6/7 year work experience. Travel & Work Arrangements/Requirements Travel 70% time. Passport Required Key Competencies Absolute KEY skills needed for role Handon experience over repair of Big Rotary Machines or similar products Product knowledge of Liquid Ring Vacuum Pump and CF Blowers or big rotary machines. Humble and pleasant in nature Fluent in languages. SAP knowledge Negotiation skills for generating Service Revenue Lean on us to help you make life better We think and act like owners. We are committed to making our customers successful. We are bold in our aspirations while moving forward with humility and integrity. We foster inspired teams. Bicycle rights prism poutine austin. Drinking vinegar gluten-free iceland, typewriter farm-to-table selfies XOXO food truck four loko. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request and a member of our team will contact you.

Senior Service Engineer Job Details | Ingersoll Rand Careers Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Service Engineer DL, IN, 110064 Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division & part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effective planning to organize installation activities in time. Coordination between engineering and quality for product issues. Timely resolution of Customer complaints. Development of Dealer Service capabilities for field service to end user to avoid load. Payment follow up for Service billings Basic Qualifications (Essential qualifications, language, driving licence etc) Bachelor of Engineering Mechanical with 6/7 year work experience. Travel & Work Arrangements/Requirements Travel 70% time. Passport Required Key Competencies Absolute KEY skills needed for role Handon experience over repair of Big Rotary Machines or similar products Product knowledge of Liquid Ring Vacuum Pump and CF Blowers or big rotary machines. Humble and pleasant in nature Fluent in languages. SAP knowledge Negotiation skills for generating Service Revenue Lean on us to help you make life better We think and act like owners. We are committed to making our customers successful. We are bold in our aspirations while moving forward with humility and integrity. We foster inspired teams. Bicycle rights prism poutine austin. Drinking vinegar gluten-free iceland, typewriter farm-to-table selfies XOXO food truck four loko. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request and a member of our team will contact you.

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals lives better makes life better - join our team today! Position Description: The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drugs with global regulatory agencies. This role also executes CMC regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions. Functions, Duties, Tasks: Design/develop CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance Maintain a positive collaboration and partnership with internal groups in RD, Quality and manufacturing Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco Lead CMC submission preparation to provide high quality submissions to multiple geographies Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams Lead and implement all global CMC submission activities for assigned projects/products, while applying the global strategy into submissions. Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends Provide training to CMC team members, as necessary Core Competencies: Strong knowledge of FDA/CVM and EMA guidelines Experience with CMC registrations in the US and/or Europe Strong communication skills, both written and oral Ability to make decisions when there is no clear right or wrong answer Self-starter, takes initiative Timeline driven Attention to detail Quality and customer focused mindset Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time Minimum Qualification (education, experience and/or training, required certifications): Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,) Minimum Experience: 5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management Additional Preferences: Understanding of the cGMP requirements Experience working with Regulatory Information Management Tools and Systems Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cross-functional teams or local affiliates for submission documents and verification of packages. Updating relevant submission tracker. PSUR submission support: Review of EURD updates Tracking licenses for DLP and PSUR submission. Review of draft PSUR document for accuracy of the data. Co-ordinate with different stakeholders for safety related information for PSUR Support submission and handling of queries for PSUR Renewal support: Tracking of licenses for registration and approval. Tracking of approval validity of licenses and renewal timelines. Planning for renewal submission. Co-ordination with cross-functional team for Renewal documentation. Co-ordination with Local RA lead for Renewal documentation and submission. Preparation of Renewal package. Submission of Renewal to health authority and post submission activity. Deliverables: Provide weekly updates (at a minimum or based on client requirement) to relevant colleagues or Project Manager on project status. Internal & Confidential [not for external circulation] Ensure that regulatory standards and timelines are met for all projects. Planning and tracking the status of ongoing regulatory projects Use of regulatory database and IT tools where relevant. Project review every quarter on performance feedback and scope of improvement. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of 4-5 years of experience working within a Regulatory Affairs Department (e.g., parmaceutical, cosmetic, food supplements, etc.), with direct accountability for deliverables or a combination of direct Regulatory Affairs experience and specific interactions with a Regulatory Affairs Department by providing source documentation to CMC, Quality, or Regulatory Operations.

JOB DESCRIPTION Designation Field Service Engineer /Service Engineer Department One GW Service Modality GE Ultrasound Relevant Work Experience Freshers - Minimum 5 years Languages to know - Kannada & English Business Importance of the Role: This role owns and drives service business results as per the operating plan of Genworks IVD solutions, manage high level of OEM & Customer satisfaction through Service Excellence at cluster level. Setting up a new service repair center and drive consumables, accessories, AMC and CMCs sales on time with excellent customer rapport will be the key drivers of initial success in this role. Key Responsibilities to Deliver (Daily, Weekly, Monthly, Quarterly, Annual): Perform breakdown maintenance, AMCS (Annual Maintenance Contract Services), CMC (Customer Maintenance Contract) services for biomedical equipment. Conduct preventive maintenance tasks to ensure optimal performance of medical devices and instruments. Troubleshoot issues with medical equipment and provide timely resolutions to minimize downtime. Collaborate with customers to understand their requirements and deliver customized solutions for servicing needs. Maintain accurate records of work performed, including repairs, maintenance schedules, and inventory management.

Summary Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role Major accountabilities: Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned Coordinate data/KPIs required for reports within RA CMC Support project teams for document finalization, collate ancillary documents requirements from various sources (e. g. databases, OneNote, trending etc. ) and support coordination and management through the appropriate system Coordinate, prepare and track CMC submissions for delivery to RA Operations Perform super-user role of RA CMC documentation system/ support super-user for e. g. account requests/ modifications as assigned Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System Support other GSOC team members for end-to-end submission coordination Key performance indicators: High quality regulatory submissions and operational documentation Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems Build and maintain collaborative partnerships with stakeholder Partner with other GSOC team members to ensure business continuity Minimum Requirements: Work Experience: If University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry Working experience in pharma industry data systems and data management Ability to work successfully with global project teams and prioritize activities considering timelines and workload Effective planning, organizational and interpersonal skills Prior publishing experience desired Computer literacy/IT systems literacy: Excellent data processing skills Skills: Being Resilient Digital & Technology Savvy Continuous Learning Interpersonal Savvy Operational Excellence Project Excellence Education: Minimum: General qualification for university entrance or completed vocational training Desirable: Science Degree (e. g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Languages: Fluent English required (oral and written). Good written/spoken communication skills Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Wte Infra Projects Pvt Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. General Management Lead according to Eurofins Leadership Charter and act as a role model for leadership and people. Eurofins leadership principles give a very large degree of autonomy to each business leader (within agreed upon financial and operational performance measures). Act as a Eurofins representative, a shareholder representative, a member of the board or as Managing Director (MD) in the holding and/or operating companies under their scope. Be interim president of operating companies as and when needed. Foster an environment which stimulates open communication, creativity and imagination, and engenders a team spirit in problem-solving and identifying, capturing new business opportunities. Lead the preparation of annual budget and 3 years mid-term plan. Report on any deviations to agreed upon results and work closely with finance. Corporate Strategy Develop strategic plans regarding; service and products offering, portfolio expansion, white space opportunities to maximize profitable growth. Work with reporting manager and regional leadership for acquisition of niche technologies and companies or assets that are synergistic to the business. Drive competitive positioning and strategy; new business development; portfolio expansion; costs reduction; and other initiatives to drive increased revenue growth and profitability. Participate in Key Account and relationship management as needed. Work with peers to ensure cross-selling synergies between CDMO Services and other service offering in the Pharma R&D space Operations Accountable for the delivery of P&L and other key financial parameters Accountable for utmost quality in delivery of services and customer satisfaction Lead the expansion of service offering through new infrastructure and inorganic growth. Ensure group systems policies and processes are adhered to in the business line under his/her responsibility. Ensure highest level of Customer satisfaction People Motivate, retain, develop and recruit excellent leaders for each of their business units and sub business units. Define and agree goals and milestones with the team leaders and ensure goals are defined and communicated to their respective teams. Set up Key Performance Indicators (KPIs) to monitor progress. Follow up as appropriate and become hands on if required to ensure achievement of goals. Implement strong performance management and team development processes along group recommendations and using group tools when available. Assess current talent and ensure that there is a highly committed and capable leadership team in place and that these leaders are coaching and mentoring potential successors and incumbents and/or bringing in additional talent as needed. Qualifications Experience Minimum of 20 years working experience, of which at least 5 years with full P&L responsibility or in a techno-commercial role. Proven leadership and business development experience. Previous experience in a Contract Research / CDMO company would be a requirement A successful, fast-track career with clear progression that has not yet reached its full potential. Education Masters or PhD Organic Chemistry with MBA or business exposure Knowledge, Skills, and Abilities Knowledge of Pharma R&D outsourcing market in General and CMC / CDMO Services is a must A hands-on attitude with an excellent understanding of financial matters A successful people leader with a focus on business and its development. Additional Information We support your development! Do you feel you dont match 100% of the requirementsDont hesitate to apply anyway! Eurofins companies are committed to supporting your career development. Weembracediversity! Eurofins network of companies believe in strength and innovation through diversity, being anEqual Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page:https://careers.eurofins.com/ Company description: Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, research services.It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 origin, traceability and purity of biological substances and products. In 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.

Main Responsibilities Sourcing Expertise & experience in CDMO/CMC/Chemistry/Toxicology Exposure to import of Specialty chemicals from China Extensive experience on Cost Sheets. Experience in import and its related formalities to ensure timely clearances and delivery of imported Goods (Lab equipments and chemical/consumables) Procurement of Biologicals & Consumables Liaison with Regulatory Authorities Develop, lead and execute purchasing strategies. Track and report key functional metrics to reduce expenses and improve effectiveness. Craft negotiation strategies and close deals with optimal terms. Partner with stakeholders to ensure clear requirements & documentation. Forecast price and market trends to identify changes of balance in buyer- supplier power Perform cost and scenario analysis, and benchmarking. Assess, manage and mitigate risks. Seek and partner with reliable vendors and suppliers. Determine quantity and timing of deliveries. Rate contracting of all Opex related requirements. To arrange for vendor approval after obtaining of duly filled in Vendor Questionnaire Ensure timely, cost effective and high-quality materials adhering to all purchase policies and regulatory guidelines. Review and approval of Stores Records Competencies Proven working experience in Biopharma industry. Strong leadership capabilities Working with teams, leading them Senior profiles from the industry who has worked in a shared service profile and who has the potential of moving into a senior role in near future. Comfortable and has worked in different industries and segments especially large MNCs and proprietor driven organizations. Candidate who has managed purchase savings. Candidates with dynamic personality and strategic purchase know how Exposure to Techniques of Cost Reduction Exposure to Techniques of Negotiation Knows Key KPIs of purchase department. Familiarity with sourcing and vendor management Interest in market dynamics along with business sense Working experience of vendor management software like Coupa. Ability to gather and analyze data and to work with figures. Solid judgement along with decision making skills. Knowledge of Indirect and Capex procurements Ambitious, looking for leadership role. Has had lateral movements Cross Industry Entrepreneurship Skills Comfortable working in a fast pace environment and who can put processes into place. Qualifications Any graduate Diploma/Degree BE/ MBA good to have.

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57

Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities in Europe, UK. Lead the preparation, review, and submission of high-quality regulatory CMC documentation. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs). Monitor and interpret global regulatory requirements and industry trends related to CMC and life cycle management. Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations. Lead or support meetings and interactions with regulatory authorities, as required. Maintain awareness of and help implement changes related to product quality systems, quality investigations, risk assessments, and change controls. Represent Regulatory CMC in cross-functional teams and support regulatory strategy for product life cycle management plans.

Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have very good technical understanding of the tool

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills. Project Management. Regulatory Compliance. Risk Assessment. Risk Management. Languages : English.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Experience and Educational Requirements Several years experience, or demonstrable capability, in area of responsibility on similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks. University degree in Life Science. Minimum Skills, Knowledge and Ability Requirements Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures. Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision. Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-today working level as we'll as clients team lead level. Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance. English business fluent

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead. General guidance (consultancy) of colleagues and clients regarding CMC Services. Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues. Support with VDC strategy implementation and optimization. Comply with and support the maintenance of internal procedures. Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead. Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries. In agreement with Head of VDC REG providing on-site regulatory support to GCS clients. The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG. Experience and Educational Requirements Several years experience, or demonstrable capability, in area of responsibility on similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks. University degree in Life Science. Minimum Skills, Knowledge and Ability Requirements Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures. Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision. Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope. Ability to manage internal and external (client) relationships on operational / day-today working level as we'll as clients team lead level. Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance. English business fluent

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. General Review of plant Site Master File, layouts, and valid GMP Compliance Certificate for its adequacy to support regulatory submission. Effectively implement post-approval commitment. Preferred candidate profile Review of CMC (Chemistry, Manufacturing, and Controls) Documents Self-motivated, detail-oriented, and highly organized professional Proven ability to collaborate and communicate effectively with diverse teams Proficient in Microsoft Word, Excel, and PowerPoint Fluent in English, with strong skills in speaking, comprehension, reading, and writing. Strong technical expertise in reviewing manufacturing site documentation.

Summary The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes. About the Role Major accountabilities: Performs strategic planning of more complex and/or accelerated projects with e.g., multiple candidates / scenarios, or of several projects with varying timescales. Has sense of urgency, aligns, and coordinates multiple activities in complex plans. Establishes realistic project timelines to achieve milestones and goals, organizes additional resources if needed to fulfill planning, tracks progress and takes actions if obstacles emerge or priorities change. Establishes technical development plans in line with priority classification of project, gated by clinical readouts as appropriate and with an enterprise view in consideration of overall portfolio priorities. Establishes high level summaries for presentation to management and stakeholders. Has advanced skill to identify, assess, manage, and communicate CMC risks / program risks. Due to seniority and experience, can handle more difficult risks, issues in more complex projects and handle multiple risks of DS/DP/Device even with junior CMC team members. Provides drug development expertise in addition to technical expertise. Follows standard process but at the same time thinks outside the box based on existing knowledge. Challenges the status quo, is curious and fosters creativity of team members and own creativity. Leverages existing knowledge and implements in EPT/GPT strategy. Continues to follow and stands behind EPT/GPT decisions. For complex late phase programs, Senior TPL supports defined work packages. Build relationships by identifying common interests and priorities with a variety of people inside and outside the organization. Has deeper understanding of current organizational structure, establishes networks and uses own network to resolve challenging situations and manage/drive change. Participates in boards and joins and/or can lead discussions in leadership teams. Is highly skilled in collaborative settings (i.e., external vs internal, CROs, DDs, in-/out-licensing settings). Approaches/analyzes issues and collaborates with other line functions for optimal solutions. Takes into account multiple stakeholder perspectives and approaches to find optimal solutions and build commitment and consensus. Provides knowledge of industry, main competitors, customers and external environment - this includes healthcare industry and global industry, digital and technological advancements. Shares knowledge with CMC community, e.g., by lessons learned sessions. Uses knowledge and experience to challenge and influence CMC line functions and/or EPTs/GPTs in background of the overall drug development strategy / industry insight. Actively contributes to EPTs/GPTs beyond CMC line functions. Is able to navigate and manage the complexity of the dis-ease area GPTs. Leads DDs for assets in development. Is able to cope with time pressure and senior management exposure. Relates to people in an open, friendly, and accepting manner. Understands the formal and informal channels for exchange of ideas and provides constructive feedback. Reacts tactfully when receiving advice, instruction or critical feedback and openly gives and receives feedback. Remains calm and objective and demonstrates respect, composure, and professionalism during difficult circumstances, including difficult interpersonal situations. Learns to manage teams/stakeholders appropriately (utilizing their support). Brings forward sound proposals and shares lessons learned, without passing the blame. Anticipates setbacks and stays in control - takes criticism as intended for situations (not personally or toward particular individuals). Recovers quickly from problems and setbacks. Exhibits servant leadership and provides mentoring/coaching to junior TPLs, line functions and CMC team members to support their professional and personal growth. Leads by example and drives decisions. Minimum requirements Successfully demonstrated several years (minimum of 2-3 years) of directly related experience as functional project leader and relevant experience as Associate TPL or equivalent. Has strong scientific/technical knowledge, understands technical development tasks. Is able to establish/maintain DS/DP/Device supply plan (in alignment with CSPL). Has fundamental knowledge of GMP and regulatory requirements. Has fundamental cross-functional knowledge (PK/PD, tox, clinical, commercial) regarding drug development. Manages end to end technical drug development and knowledge. Completed basic project management training. Potential extension (not mandatory): Basic/Bronze IQP training. Is adept at using and regularly uses/updates project management tools available in TRD (e.g. Gantt charts, MS Project, Resource Cockpit). Knows fundamental IT tools. Has effective presentation skills.

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management. Skills: Change Control. Cross-Functional Teams. Documentation Management. Negotiation Skills. Project Management. Regulatory Compliance. Risk Assessment. Risk Management. Languages : English.