- Lilly (Philadelphia, PA)
- …to make life better for people around the world. Responsibilities: The Associate / Manager , CMC Regulatory and IMP Manufacturing Operations is a hybrid ... CMC 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)
- … 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 acts as ... time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional ...Include: + Generate and execute of global and country-specific regulatory strategies + Provide CMC regulatory… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
- Orchard Therapeutics (Boston, MA)
- …business priorities. This role represents a unique opportunity to contribute to Regulatory CMC activities supporting maintenance and development of Orchard's ... products in clinical development: . Participate in definition and implementation of Regulatory CMC strategy for assigned program(s). . Collaborate with Technical… 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 ... the regulatory strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is responsible for communicating the regulatory … more
- 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 ... for providing strategic direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible… 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 ... manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry + Regulatory CMC experience + Ability to develop solutions to… more
- AbbVie (North Chicago, IL)
- …Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Program Manager , CMC Dossier Management assists with the development and… more
- Vera Therapeutics (Brisbane, CA)
- …Development in project teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: * PhD/MS in relevant life ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions and associated quality… more