- 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 ... 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 ... more
- AbbVie (Irvine, CA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... more
- Regeneron Pharmaceuticals (Troy, NY)
- …of responses to regulatory agency inquiries. + Act as the project manager related to program submission strategies, including timelines, approach, and ... more
- AbbVie (North Chicago, IL)
- …the development and oversight of Chemistry, Manufacturing, and Controls ( CMC ) strategic project plans to support CMC regulatory deliverables such as ... more
- West Pharmaceutical Services (Exton, PA)
- …latest guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs ... more
- Fresenius Medical Center (Knoxville, TN)
- …to comply with regulatory requirements + Organization of submission-readiness of regulatory documentation (eg, CMC relevant parts) + Organize and support ... more
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... more
- Merck (West Point, PA)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... more
- Merck (West Point, PA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... more
- Integra LifeSciences (Plainsboro, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The **Senior Project Manager ** is a key member of the value stream leadership team ... more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary:** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC ... more
- Gilead Sciences, Inc. (Foster City, CA)
- …therapy E&L program including end-to-end E&L risk assessment, testing lab management and regulatory filing support. In addition, the Sr Manager will support ... more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... more
- AbbVie (North Chicago, IL)
- …Drug Product Development, Molecular Profiling and Drug Delivery, Quality Assurance and CMC - Regulatory . Responsibilities: + Mentor/supervise a team to support the ... more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... more
- Eurofins (Philadelphia, PA)
- …GMP product testing laboratories worldwide. Eurofins BPT provides comprehensive CMC laboratory services for the world's largest pharmaceutical and biopharmaceutical ... more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Program Manager is an experienced leader responsible for managing large global projects ... more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **The Senior Manager ,** **GPV Compliance & Business Management will support the** **leads of Global PV** **Audit & Inspection readiness** **(AIR)** ... more
- Amgen (Washington, DC)
- …with domestic and international CMOs/CROs + Solid understanding of cGMP, Regulatory / CMC , legal, quality requirements, and import/export policies + Self-starter ... more
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