125 Cmc Jobs - Page 3

Experience Level: 4 to 6 Years Qualification: B.E., Electrical / E&TC Work Location: Pune Notice Period: 30 days Candidate should have experience in development of electronics components like PCB, Cell Module controller (CMC) and High voltage/ Low Voltage connectors. I have attached JD for your reference. Job Description: Roles & Responsibilities: Development of Cell module electronic components like connectors, Cell module controller etc. Voltage, Current, Resistance calculations for development of busbars and HV components. Electric layout design of the cell module. Coordination with the supplier and cross functional teams for development of electronic connectors. Clearance and creepage calculation of Cell module. Component level test planning preparation. Additional Skills: Good Knowhow of Battery pack components and eMobility system. Knowhow of design guidelines for designing HV system. Good to have knowledge of CATIA V5 3D designing of the parts and 2D. Good to have experience in OAS (Open Architecture System) and its integration into design process. Problem-solving skills. Teamwork and communication skills, as design projects are often interdisciplinary. Good knowhow of electronic components and electric circuits is must. Good analytical skills required. Autocrear tool know how is additional advantage.

Christian Medical College is looking for Project Co ?? Ordinator / Junior Research Fellow / Senior Research Fellow for the Department of Clinical Haematology (Job Code-1603 ) to join our dynamic team and embark on a rewarding career journey Research Support: JRFs work under the guidance of senior researchers or principal investigators on research projects They assist in conducting experiments, data collection, literature reviews, and data analysis Data Collection and Analysis: Collecting and recording data from experiments or research studies and using appropriate software or statistical tools for data analysis Literature Review: Conducting comprehensive literature reviews to understand the current state of research in the field and to inform the research design and methodology Experimental Work: Depending on the field, JRFs may perform laboratory experiments, fieldwork, surveys, or other research activities specific to their project Documentation: Keeping detailed records of research procedures, findings, and outcomes This documentation is critical for the research process and for publishing research results Research Proposal Writing: Assisting in the preparation of research proposals and grant applications to secure funding for research projects

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , Annual notification and labelling approval for US and OAM b. Review of change control and file variation as per country requirement 4. Regulatory compliance: a. eCTD compilation b. Ensure reposition of comprehensive product information into central repository C. Review regulatory filing impact of variations, change controls, etc.

Role & responsibilities Please find your responsibilities and job description as under: 1. Handling Purchasing of Services (e.g. AMC/CMC, Calibration of Equipment & PT Participation) and Supplies (e.g. Lab Equipment, Chemical & Consumables). 2. Handling purchasing of Capex requirements. 3. Planning and budgeting of purchase functions, involving cost estimation, contract negotiations. 4. Collecting Data for Monthly requirements from all departments (including chemicals, Glassware, stationary and all related things required in lab), merging all data, taking approval. 5. Managing and coordinating for lab Purchase including chemical, glassware and for any other lab related activities 6. Follow ups from vendor for the delivery of requirements. 7. Timely clearance of payments & handling vendor inquiries. 8. Creating PO and process invoice of vendors in EMS module. 9. Responsible for purchase, quotations, sampling, sample registration, reporting & invoicing. 10. Managing sample registration team and guiding them in case of any issues. 11. Supervising reporting team for timely report delivery with zero error. 12. Organizing runners for collection of samples (s) as per clients requirement. 13. Sample receiving, sample booking, and sample distribution to respective departments, Preparation of Quotation, report & invoice, when required and maintaining TAT sheet. 14. Interact with customers to provide information in response to inquiries about services. 15. Daily update of Booking, reporting, Invoice and maintain Food daily matrices on daily basis. 16. Maintain 5 X 5 Data on monthly basis. 17. Operation Based Sales. 18. Other works allotted time to time as when required.

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Regulatory Affairs Associate III- RA CMC Lifecycle EMSO APAC Date: Jun 18, 2025 Location: Navi Mumbai, India, 400706 Company: Teva Pharmaceuticals Job Id: 62484 Who we are How you ll spend your day Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market. Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders. Responsible to keep trackers and database up to date. Briefing the regulatory status in different forums associated with cross functional teams. Experienced in managing software related to Regulatory Affairs and QMS. Your experience and qualifications Academic Degree/PG and thinking level with a chemical/pharmaceutical background. 6+ years of experience in CMC Regulatory Affairs; Europe and International Market preferred. Knowledge on EU registration procedures and pharmaceutical regulations. Good communication skills (written and oral). Interest and capability to work with different software, including Document Management Systems. Accurate, able to prioritize and work according to agreed timelines. Working independently with a moderate level of guidance and direction. Solve complex problems using existing solutions and support. Identify & implement process improvements. Team player Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Primary Skills required. Responsible for authoring and review of CMC sections of regulatory submissions, including Modules 2 and 3, for INDs, IMPDs, CTAs, BLAs, and MAAs, as well as briefing packages and health authority responses.. Developing, reviewing, and ensuring the completeness of CMC sections within IND and IMPD applications.. Ensure all documents are authored in accordance with regulatory guidance (FDA, EMA, ICH).. Good understanding of analytical method development, validation, comparability and biosimilarity assessments, upstream and downstream process development.. Provide peer review and mentorship to junior writers or team members, ensuring consistency and scientific accuracy across deliverables.. Experience with post-approval changes, tech transfers, and product lifecycle management.. Excellent written communication, scientific writing, and document organization skills.. Stay current with evolving regulatory expectations and industry best practices related to CMC submissions for biologics and biosimilars.. Secondary Skills Required. Deep understanding of CMC regulatory requirements for biologics/biosimilars, including ICH and region-specific guidance.. Experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics.. Qualifications. Minimum 8 years of experience required for CMC-Biologics along with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Senior Demonstrator (NM) for the Department of Immuno Hematology and Blood Transfusion Qualification: M.Sc. in Medical Lab Technology Experience: Candidates applying for Senior Demonstrator (NM) post should have completed 4 years as Demonstrator (NM) in CMC. Coordinate the BSc MLT course and also provide laboratory diagnostic services. Job Preference: Worked as AHS Course Coordinator for a minimum of 3 years in an academic institution. Salary: As per institutional Rule Accommodation not Provided 21/06/2025

Sona BLW Precision Forgings Limited Job Description JD Code QTY12 Department Quality Designation Engineer / Sr. Engineer Reports to DGM In Process Quality Qualification BE (Mech/EEE) Preferred industry Automotive Industries Experience 5-8 years Location Chennai JOB DESCRIPTION Job Purpose: In-process Quality Key Accountabilities / Responsibilities: Do process Audit Basic understanding of Processes Verification for APQP and PPAP elements Interpretation of Drawing and ES. Problem solving using 8D Perform DOE to understand variation, and resolve dispute. Documentation to confirm to TS 16949 Handling of measuring instruments, and use of first principle measurement techniques. Effective written and oral communication. SCR, CMC verification Long term and short term process capability study. Key Performance Indicators: Audit Compliance Internal Audit/ External Audit/Customer Audit. Internal and external Audit - Coordination TS documents in line with Current Practice, Updation of documents in line with Customer specific requirements. Driving for Improvements in the Process/Product Rejection reduction project through problem solving Techniques. Person/Competency Specification Essential:Desirable:Knowledge: Basic knowledge on Analytical Tools Basic knowledge on Quality concepts Knowledge on Quality Tools Personal SkillsAttributes: Good attitude to learn Dynamic / go getter Good communication skills Group work culture Key Functional Competencies: Capable of doing product, Process Audits Key Leadership Standards: Team member to participate in small group activities. Follow systems and be predictable Participate in other activities apart from regular work. Form NumberHR-FR-23Revision Number01OriginatorHRRevision Date27- Mar23

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per checklist of CDSCO MD Rules 2017. Submission of WholeSale & Retails Licence. Labelling and Implementation of Medical Devices, Drug product, Biological product & Cosmetics products. Requirements: Education: Bachelors/Masters degree in Pharmacy, Life Sciences, or a related field. Experience: 3-5 years in Regulatory Affairs within the pharmaceutical, biologics, or medical device industry. Skills: Knowledge of CDSCO, WHO-GMP, and CTD guidelines, experience in dossier preparation & regulatory submissions, strong coordination skills, and understanding of Medical Device Rules 2017. Important Note: "For the first 6 months, the training will be at the Head Office located in Chennai. Travel expenses and accommodation will be provided by the company." Contact us; Siva - 7826802077 Email Id - azaruddin.a@lifecell.in sivaprasad.m@lifecell.in

Responsible for developing and implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of all regulatory milestones for moderate to less complex projects through the product lifecycle including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, postapproval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance). Demonstrated ability to generate innovative solutions to 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, and interpersonal skills. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Adaptability, Business Processes, Communication, Communication Management, Detail-Oriented, Document Coordination, Electronic Common Technical Document (eCTD), Employee Training Programs, Financial Statements, Interpersonal Relationships, Management Process, Manufacturing, Mentorship, Project Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation, Regulatory Research, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Risk Management and Mitigation {+ 4 more} Preferred Skills: Job Posting End Date: 06/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Role & responsibilities Revenue Management: Develop and implement strategies to meet or exceed service revenue targets for AMC, CMC, spares, spot visits, PM kits, QC kits, and consumables. Analyze market trends and customer needs to identify new revenue opportunities and enhance existing service offerings. Commercial Operations: Oversee all back-office operations related to commercial activities, including invoicing, payment processing, and collection. Streamline processes to improve efficiency and accuracy in billing and collections. Ensure compliance with regulatory requirements and company policies. Cross-Functional Collaboration: Work closely with sales, marketing, finance, and technical teams to drive service revenue growth. Provide support and guidance to the sales team on service-related offerings and pricing strategies. Performance Monitoring: Establish key performance indicators (KPIs) to track service revenue performance and operational efficiency. Prepare regular reports for senior management on revenue performance and operational metrics. Team Leadership: Lead, mentor, and develop the commercial operations team, fostering a culture of excellence and continuous improvement. Conduct regular training sessions to ensure team members are knowledgeable about services and processes. Preferred candidate profile Bachelors degree (MBA preferred) Proven experience in commercial operations management within the in-vitro diagnostics or healthcare industry. Strong understanding of service revenue models and operational processes. Excellent analytical and problem-solving skills. Exceptional communication and interpersonal skills, with the ability to work collaboratively across departments. Proficiency in CRM and ERP systems, as well as Microsoft Office Suite.

Sona BLW Precision Forgings Limited Job Description JD Code QTY12 Department Quality Designation Engineer / Sr. Engineer Reports to DGM In Process Quality Qualification BE (Mech/EEE) Preferred industry Automotive Industries Experience 5-8 years Location Chennai JOB DESCRIPTION Job Purpose: In-process Quality Key Accountabilities / Responsibilities: Do process Audit Basic understanding of Processes Verification for APQP and PPAP elements Interpretation of Drawing and ES. Problem solving using 8D Perform DOE to understand variation, and resolve dispute. Documentation to confirm to TS 16949 Handling of measuring instruments, and use of first principle measurement techniques. Effective written and oral communication. SCR, CMC verification Long term and short term process capability study. Key Performance Indicators: Audit Compliance Internal Audit/ External Audit/Customer Audit. Internal and external Audit - Coordination TS documents in line with Current Practice, Updation of documents in line with Customer specific requirements. Driving for Improvements in the Process/Product Rejection reduction project through problem solving Techniques. Person/Competency Specification Essential:Desirable:Knowledge: Basic knowledge on Analytical Tools Basic knowledge on Quality concepts Knowledge on Quality Tools Personal SkillsAttributes: Good attitude to learn Dynamic / go getter Good communication skills Group work culture Key Functional Competencies: Capable of doing product, Process Audits Key Leadership Standards: Team member to participate in small group activities. Follow systems and be predictable Participate in other activities apart from regular work. Form NumberHR-FR-23Revision Number01OriginatorHRRevision Date27- Mar23

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

? ?Job Description ?As a Support consultant it consists maintenance activities of the developed reports and projects. -Maintenance of BI launchpad CMC -Resolving the issues/incidence came from the business in the developed project and reports -All the admin activities and managing CMC(central management console) -Maintenance and checking server and server groups -Managing security profiles. -Upgradations, migration activities related to the system. -Managing folders, documents, reports, dashboards, connections, web services and universe in repositories. -Create User access levels and provide the access to users -Managing BOBJ License

Job Summary: We are seeking a Regulatory Affairs Specialist with 4 to 8 years of experience in compiling, preparing, and submitting regulatory dossiers in accordance with European regulations (EMA/EU). The ideal candidate will have a proven background in injectable drug products and will ensure regulatory compliance throughout the product lifecycle, working closely with cross-functional teams and regulatory agencies. Key Responsibilities: Prepare, compile, and review regulatory submissions for the EU region, including CTA, MAA, Variations, Renewals, and PSURs/DSURs. Ensure dossiers comply with EMA and national regulatory authority requirements, including eCTD/NeeS formatting. Maintain product registrations and ensure timely submission of updates, renewals, and amendments. Liaise with internal departments (e.g., R&D, Quality, Clinical) to collect and verify data for regulatory submissions. Respond to queries from European regulatory agencies and prepare responses to deficiency letters. Monitor changes in EU regulatory requirements and assess the impact on products and documentation. Contribute to regulatory strategy development during all phases of the product lifecycle. Manage electronic submission tools and regulatory databases. Assist in audits and inspections to support compliance with regulatory expectations. Required Qualifications: Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field. 4–8 years of hands-on experience in EU regulatory dossier preparation and submissions. Experience in regulatory submissions specifically for injectable drug products is mandatory. Strong knowledge of EMA guidelines, EU regulations (including 2001/83/EC and 2017/745 for medical devices if applicable). Experience with eCTD software and publishing tools. Understanding of regulatory procedures: CP, DCP, MRP, and national submissions. Excellent written and verbal communication skills. Strong project management and organizational abilities. Preferred Skills: Experience in a CRO, pharmaceutical, or medical device company. Knowledge of regulatory requirements beyond the EU (e.g., UK MHRA, Swissmedic). Experience with regulatory intelligence tools and databases.

CirrusLabs Private Limited is looking for SAP BO Developer to join our dynamic team and embark on a rewarding career journey Requirements Gathering: Collaborating with business users and stakeholders to understand their reporting and analytics requirements You gather and document functional and technical requirements, ensuring a clear understanding of the desired outcomes Design and Development: Designing and developing SAP BO solutions based on the requirements This includes creating universes (semantic layer) that define the business logic and data relationships, building queries, and designing reports and dashboards using SAP BO tools such as Web Intelligence, Crystal Reports, and Dashboard Design Data Integration: Integrating data from various sources into the SAP BO environment This may involve extracting data from databases, data warehouses, or other systems, transforming and cleansing the data, and loading it into SAP BO for reporting and analysis Report and Dashboard Development: Creating and customizing reports and dashboards using SAP BO tools You design visually appealing and interactive reports that present data in a meaningful way, enabling users to analyze and gain insights from the data Data Analysis and Visualization: Using SAP BO tools to perform data analysis and visualization tasks This includes creating charts, graphs, and other visualizations to represent data trends, patterns, and key performance indicators (KPIs) You apply data analysis techniques to identify business insights and trends You have an entrepreneurial spirit. You enjoy working as a part of well-knit teams. You value the team over the individual. You welcome diversity at work and within the greater community. You ar

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

About your role We have vacancy for CMC expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. This individual will be based in Mumbai. The candidate has the possibility to utilize his/her own strengths with the support of the professionals. Your key responsibilities Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work) To prepare response to regulatory deficiencies letters according to EU regulatory requirements To collaborate with other departments/partners To maintain lists/documents/records Responsible for keeping Orion internal regulatory system up to date and accurate To achieve his/her responsibilities within the agreed timescales To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating Other possible tasks appointed by Supervisors What we offer An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group Possibility to utilize your own strengths with the support of the professionals Flexible, high-spirit working environment where your skills are appreciated Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times). Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https: / / www.orion.fi / en / careers / orion-as-an-employer / . Our expectations 5 - 8 years work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines. Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage. Fluency in oral and written English Ability to work well independently as well as in a team environment Task oriented with learning attitude and Team work skills Familiarity with Microsoft Office Qualification: Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / University How to apply and additional information Email your CV on recruitmentindia@orion.fi & please share below details, - Required documents, CV/Resume - Current CTC, Expected CTC & Notice Period. - Application deadline - 30.06.2025

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

What you will do Let’s do this. Let’s change the world. 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. In this vital role you 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 Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams 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, postmarket 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members 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 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.

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead. The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Manager include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies Provides expertise and guidance to interdepartmental and cross-functional teams Coaches and support junior regulatory staff’s career development Identifies and implements process improvements for the change management process What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry 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

Interested candidates share resume to sanjay.behera@thyrocare.com or whatsapp to 8928285213 Freshers can apply Administrative Duties: Oversee daily administrative operations of the lab facility. Coordinate procurement of office/lab supplies and maintain inventory. Manage service contracts, AMC/CMC for lab equipment and utilities. Vendor coordination and negotiation for services and repairs. Documentation and maintenance of facility-related records. Handle visitor management and front-desk support, if required. Electrical Maintenance: Perform routine checks and preventive maintenance of electrical systems (UPS, HVAC, panels, generators, etc.). Troubleshoot and repair minor electrical issues promptly to avoid downtime. Coordinate with external electrical service providers for advanced issues. Ensure backup power systems (generators/inverters) are operational. Monitor energy usage and suggest improvements for efficiency. Facility Management: Supervise housekeeping, pest control, waste disposal (biomedical/non-biomedical). Ensure compliance with NABL/NABH/ISO and other regulatory standards related to infrastructure. Monitor safety systems (fire alarms, extinguishers, CCTV, access controls). Coordinate periodic deep cleaning, fumigation, and preventive maintenance. Support in renovation, space planning, or setting up new lab facilities. Requirements:Education & Experience: Diploma/ITI in Electrical Engineering or equivalent. 0-5 years of experience in a similar role, preferably in healthcare/lab settings. Familiarity with biomedical equipment is an added advantage. Skills: Strong troubleshooting and problem-solving skills. Good understanding of electrical systems and facility protocols. Proficient in MS Office and basic facility management software. Good communication and coordination skills. Ability to handle emergency breakdowns and multitask.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP UI5 Development Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring that the applications are developed according to specifications and delivered on time. Your typical day will involve collaborating with the team to understand the requirements, designing and developing the application, and testing and debugging to ensure its functionality and performance. Roles & Responsibilities: Expected to perform independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work related problems. Collaborate with the team to understand the application requirements. Design and develop SAP UI5 applications based on the specifications. Test and debug the applications to ensure functionality and performance. Collaborate with cross-functional teams to integrate the applications with other systems. Provide technical support and troubleshooting for the applications. Stay updated with the latest trends and advancements in SAP UI5 development. Assist in documenting the application design, development, and maintenance processes. Professional & Technical Skills: Must To Have Skills:Proficiency in SAP UI5 Development. Good To Have Skills:Experience with SAP Fiori, JavaScript, and HTML5. Strong understanding of SAP UI5 framework and architecture. Experience in developing responsive and user-friendly UI5 applications. Knowledge of SAP ABAP programming language. Familiarity with SAP Gateway and OData services. Experience in integrating UI5 applications with SAP backend systems. Ability to troubleshoot and debug UI5 applications. Knowledge of UI design principles and best practices. Additional Information:-Strong hands-on experience in developing custom UI5 apps-Proficiency in Fiori Launchpad configuration and customization.-Strong knowledge of JavaScript, HTML5, CSS3, and OData services.-Ability to work in a team-oriented, collaborative environment. Qualifications 15 years full time education

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