- Amgen (Washington, DC)
- … Lead** **Live** **What you will do** Let's do this. Let's change the world.The Regulatory Affairs Manager CMC Contributes to product teams and ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager -...Include: + Generate and execute of global and country-specific regulatory strategies + Provide CMC regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Amgen (Washington, DC)
- …million patients worldwide. It's time for a career you can be proud of. Regulatory Affairs CMC Senior Manager **Live** **What you will do** The CMC ... strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is...+ Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff +… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …portfolios assigned. **A typical day may include the following:** + Responsible for CMC product development activities from a regulatory standpoint during early ... submissions and post market requirements for Cell and Gene therapies + Provide regulatory interpretation, position and strategy for global CMC /CP regulatory … more
- Vera Therapeutics (Brisbane, CA)
- …including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs , Supply chain, Finance, and Program Management. Write ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: *… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …The purpose of this position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Actalent (Morristown, NJ)
- Job Title: Regulatory Affairs AssociateJob Description We are seeking a highly skilled and motivated Regulatory Affairs Associate with extensive ... to FDA queries and a background in the pharmaceutical industry, specifically in regulatory affairs . This role requires a strong understanding of FDA guidelines… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… more