124 Cmc Jobs - Page 5

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and 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: Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, 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. Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. As needed, coordinate /collect /store source documentation needed for direct submission to Health Authorities. Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed. 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 regulatory documentation -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 accurate information / communication about project documentation specific issues within own department and to key stakeholders. RA CMC regulatory documentation follows Novartis guidelines meets regulatory guidelines. Builds maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Project Management. Operations Management and Execution. Collaborating across boundaries. Skills: Documentation Management. Lifesciences. Operational Excellence. Regulatory Compliance. Languages : English.

Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing Control). This applies to sector-specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements. Supporting change - and inspection management within the QA Compliance Team. Key Responsibilities: Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date. Conducting training to ensure appropriate knowledge and regulatory compliance. Supporting the area in effective change control. Examination of reg. relevance and pre-evaluation amendments to Novartis products and customer products. Contact person for regulatory matters and intermediary between RA CMC and production unit at strategy decisions and in the product life cycle. Support of timely reviews of CMC documents for defined products; Support with and Identification of challenges in the course of regulatory compliance audits. Implementation and overview of initiatives to improve (regulatory) compliance. Coordination, guidance, and support in the preparation of CMC responses to health authorities for specific products. Essential Requirements: Advanced University or academic degree in chemistry, biology, pharmacy, engineering or equivalent. Fluent English (German desired). More than 3 years of experience in an operational GxP area, in Manufacturing, Development or QA or Regulatory Affairs; with a thorough knowledge of biologic drug substance manufacturing processes for recombinant proteins and/or nucleic acids. Ability to speak up and to take Quality decisions during challenging situations. Desirable Requirements: Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership, and project management experience. Ability to work independently and effectively in international, complex, and multifaceted environments.

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

Career Category Regulatory Job Description 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 Sr Associate 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master s degree OR Bachelor s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 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 .

Truhome Finance is looking for Branch 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

Truhome Finance is looking for Branch 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

Truhome Finance is looking for Branch 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 company€™s 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

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.

Role & responsibilities :- 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

The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new product developments and major CMC changes. Incumbent may oversee specific elements of internal compliance processes and ensure best practices are in place aligned to KPIs. The CMC Senior Manager may mentor a team of manager(s) and/or associate(s); in that case, he/she would have the overall accountability of the portfolio supported by the team. The CMC Senior Manager may be a Subject Matter Expert, bringing in the role and/or developing particular expertise in the regulations of a (set of) country/ies or on a specific field in CMC. In that role the CMC Senior Manager would be expected to provide guidance across the wider CMC team and to other functions in his/her field of expertise. Key Responsibilities Responsible for CMC regulatory matters and activities relating to new registrations and life-cycle maintenance for an assigned category portfolio of projects and products. Establishes and communicates global CMC regulatory strategy. Provide oversight/ mentorship for a portfolio and/or technical leadership on specific CMC topics Provides consistent input to project charters and plans, including Regulatory/CMC inputs into the business case for value engineering, approach, milestone plan and risk register for assigned products/projects. Works with Regulatory Category, Regional & PLM, product development, supply chain and tech excellence to assure alignment of registration strategy for all new or modified formulations and high quality of submission packages. Ensures regulatory requirements of the major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Leverages experience across regions for the allocated projects/products and provides regulatory CMC advice on a global basis. Provides CMC regulatory expert advice to the cross-functional teams including project and brand team(s) regarding new opportunity evaluations (including due diligence as required) and CMC requirements for new product development, registration and life-cycle maintenance. Interacts with other functions and Regulatory Category, Regional & PLM colleagues to deliver high quality CMC dossiers, documents and materials in accordance with business priorities (e.g. CMC sections of Briefing Books for HAs meetings, INDs/CTAs, NDAs/MAAs). Provides CMC supports to local Regulatory Affairs in interactions with local Regulatory Agencies and experts. May interact directly with local Regulatory Agencies via email, phone, or in-person meetings, depending on project/affiliate needs. Supports registrations, variations and renewals including responses to Regulatory Agency CMC questions. Participates on the Regulatory Expert Teams of Global and local Regulatory Affairs colleagues to develop and implement regulatory strategies (when required) for all countries in product scope. Ensures regulatory priorities of all major countries in project scope are considered in the project plans and considers impact of including non-priority countries. Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of internal process records. Effectively communicates (technical) regulatory requirements and guidelines, ensuring timely and complete submissions. May act as a contributor to the Global Regulatory Intelligence team handling assigned responsibilities/regions (e.g. EU for EU based roles), potentially covering medicines, cosmetics, devices and foods. May oversee parts of the overall CMC compliance process, leading improvement projects ensuring KPIs are in place. May be involved in site or Notified Body audits when required. May contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments, projects and as subject matter expert (SME). Qualifications BA or BSc- Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering), RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP Position requires practically applied demonstration of intellect and an ability to interface effectively with R&D, supply chain and commercial counterparts with credibility 8 plus years experience in Regulatory Affairs, Quality & Manufacturing Product lifecycle support ensures compliance and requires regulatory strategy and filing of submissions at a global level. Oversight of the defined products requires a strong background in medicines, devices, cosmetics or dietary supplements. List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job. .

The Senior Associate, Global Submission Management – Americas, 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 North American 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 US, Canada and South America

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process 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 will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial Management, Monitoring, and Engagement (CTMME) product team. Build technical solution per implementation project plan by working with various members of the product team and business partners. Conduct user acceptance testing with the customer, including coordination of all feedback, resolution of issues, and acceptance of the study Support requirements gathering and specification creation process for the development work. Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements Participate and contribute to process product or standard methodologies initiatives and support developers and testers during the project lifecycle. Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc. Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations. Identify and resolve technical challenges/bugs effectively . Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Computer Science Bachelor’s degree with 6 - 8 years of experience in Computer Science Diploma with 10 - 12 years of experience in Computer Science. Preferred Qualifications: Solid technical background, including understanding software development processes, databases, and cloud-based content systems. Experience with Python scripting, SQL queries, markup languages (XML, JSON) and familiarity with API-driven content delivery. Agile/Scrum experience with demonstrated success managing product backlogs and delivering iterative product improvements. Experience with product backlog management (e.g., Jira) and collaboration tools. Good-to-Have Skills: Experience with structured content management, content models, and modular content creation. Understanding of international pharmaceutical regulatory submission guidelines and processes (eCTD, ICH, CDS, USPI etc.) Basic understanding of GenAI solutions. Good communication skills, with the ability to convey complex technical concepts. Soft Skills: Excellent analytical and troubleshooting skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills. 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.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team man a gement. May m anage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development, Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment May manage staff Knowledge and Skills Regulatory CMC- specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

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 and/or Device 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 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 and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), 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 and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device 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: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process 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

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or principal for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management . Key Responsibilities Include: Generate and execute of global and country-specific regulatory strategies Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments Develop global dossiers for CMC content for initial submissions, variations and amendments Support change management activities Develop response strategy and respond to health authority questions Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans Liaise with local regulatory teams to align on filing strategy Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system Follow established department regulatory processes to ensure cross-product alignment Knowledge and Skills CMC- specific regulatory knowledge & experience Education & Experience (Basic) Doctorate degree OR Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and10 years of directly related experience OR High school diploma / GED and12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Responsibilities: Work with the regional RA team to prepare documents for the registration of OTC drugs and cosmetic products in non-EU countries. Provide regulatory support for select projects such as artwork maintenance and artwork support for legal department and other special projects on an as needed basis using a variety of systems internally Preparation and compilation of regulatory documentation for the registration and renewal of OTC drugs and cosmetic products for EMEA and local pool Support product registration in all EMEA regions including Nordics and Northern Cluster Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing Work with Kenvue regional Skin Health & Essential Health regulatory team and/or Provider Project Manager to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Creation of regulatory documents, e.g., ingredient list, regulatory clearance Manage all EU and UK cosmetics notifications Regulatory review of product specification and labeling Support Claim Table and MasterText creation Regulatory review of raw materials Regulatory review of materials change Regulatory review of formula composition Work with Kenvue cross functional partners to provide regulatory inputs for documents Regulatory review of product information file Prepare registration dossiers using regional data and liaising with manufacturing sites Support Kenvue local market contacts in their registration procedure as well as retrieving documents from APRs/GCCs Manage all cosmetic and femcare GCCs Complete market impact assessments Portfolio survey (where used of ingredients) Deliverables: Provision of weekly updates (at a minimum) to relevant Kenvue colleagues or Provider Project Manager Training off-shore colleagues with respect to raw material and formulation review and approval as well as ingredient list generation Ensuring that regulatory standards and timelines are met Creation and update of working practices for processes used between Outsource partner and North America Regulatory Affairs for Consumer products, using lessons learned approach Planning and tracking the status of ongoing regulatory projects Ensure that standards and timelines are met Use of regulatory database (RegPoint) and IT tools (GSS, CAPRI, Concerto, ArtWorks, Veracity etc.) Create and update working practices for processes used between Outsource partner and EMEA Regulatory Affairs, using lessons learned approach Plan and track resource levels required and used for regulatory support requested. Experience/Qualifications: Minimum B.S. Chemistry, Biology, or related fields Minimum of two years of experience working within a Regulatory Affairs Department (e.g., pharmaceutical, 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

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 13 yrs Work Location :Bangalore/Hyderabad/Pune/Chennai/Kolkata Required Skills, SAP BODS Interested candidates can send resumes to nandhini.spstaffing@gmail.com

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 6 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :5 to 8 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.