- Lilly (Philadelphia, PA)
- …make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid role ... Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and… more
- Lilly (Philadelphia, PA)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the ... preparation and delivery of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.… more
- Amgen (Washington, DC)
- … Affairs CMC Senior Manager **Live** **What you will do** The CMC Regulatory Senior Manager is responsible for execution and/ or coordination of ... strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is...degree and 5 years of directly related experience OR Associate 's degree and10 years of directly related experience OR… more
- Amgen (New Albany, OH)
- … Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for ... experience OR + Bachelor's degree and 5 years of Regulatory & Compliance experience OR + Associate 's...(QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop… more
- Bausch Health (Bridgewater, NJ)
- …it-where your skills and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and ... + Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities + Act as a regulatory contact with Regulatory … more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie is seeking an Associate Project Manager to drive the execution and oversight of ... to enable the early-stage pipeline. This will be in collaboration with our CMC team, CMC Product Development Director, and Delivery System Senior Leadership.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …duties as required. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability to work ... to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting...team. **Additional Responsibilities, Knowledge, Skills and Abilities:** + Global Regulatory CMC Experience is preferred. + Ability… more
- Rhythm Pharmaceuticals (Boston, MA)
- …quality culture across the board. The Manager QA will report to the Associate Director, QA CMC , based in The United States, while supporting and liaising ... our tenacity to overcome barriers, together. Opportunity Overview Rhythm is looking for a Manager Quality Assurance (QA) to play a key role in ensuring quality and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Pivotal & Commercial Formulation and Process Development** , as an **Sr.** ** Associate Scientist** . The successful candidate will contribute to the development of ... documentation practices. + Author technical documents such as protocols, reports, regulatory dossier, etc. and prepare data-focused presentations for internal and… more
- Novo Nordisk (Boulder, CO)
- …QC, Internal Chemical Development, Drug Product Manufacturing, Program Management, CMC Regulatory , Manufacturing Operations, and Contract Manufacturing ... Nordisk internal manufacturing sites. Relationships This position reports to the Associate Director of Drug Substance Development and Manufacturing. This position… more