- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, ... CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational… more
- Amgen (New Albany, OH)
- The Regulatory Affairs CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …strength and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and ... and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US … more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- BeiGene (Harrisburg, PA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that data are identified,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Sr. Scientist, Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ) ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original… more
- Gilead Sciences, Inc. (Washington, DC)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Director, CMC Regulatory Affairs Policy, Advisory and Intelligence is ... role will report directly to the Head of Policy, Advisory and Intelligence/ CMC Regulatory Affairs . **JOB DESCRIPTION** + Serve as critical and recognized,… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC ) for investigational and commercial products +… more
- Fujifilm (College Station, TX)
- …of an individual's development plan. Regulatory Affairs supports all CMC regulatory affairs activities for FUJIFILM Diosynth partner companies' ... **Position Overview** **Summary:** The Quality Assurance Regulatory Affairs Supervisor is responsible for...products, summarize regulatory intelligence, provides CMC regulatory … more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... milestones, etc. are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant … more
- Sanofi Group (Morristown, NJ)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... Research and Development. The selected candidate will oversee key regulatory activities and report to the Global Regulatory Device Head for Digital Health and… more
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