- System One (San Rafael, CA)
- Job Title: Senior Manager - CMC Regulatory Location: Hybrid - Local to San Rafael, CA Type: Contract Description: As a Senior Manager in the ... more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Senior Manager of CMC Industry and Regulatory Intelligence position. In this role, you would be responsible for ... more
- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... more
- AbbVie (North Chicago, IL)
- …to regulatory queries, and participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. risks ... more
- AbbVie (North Chicago, IL)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... more
- United Therapeutics (Silver Spring, MD)
- …cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior ... more
- Novo Nordisk (Boulder, CO)
- …ensuring the supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and ... more
- System One (San Francisco, CA)
- Title: Senior Manager , QA Operations Location: The...the company and CDMOs + Support quality review of CMC modules of regulatory submissions as needed ... more
- BeiGene (San Mateo, CA)
- …for regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and relevant data elements ... more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete clinical supply ... more
- Integra LifeSciences (Plainsboro, NJ)
- …of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream leadership ... more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …documentation quality meets established standards, with a key focus on drafting regulatory CMC submission documents. + Develop creative and collaborative ... more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Senior Manager , Manufacturing is responsible for plant production activities for ... more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... more
- Bausch Health (Petaluma, CA)
- …with accuracy and in accordance with established procedures + Effectively communicates with Manager , team members, and Senior Management + Organized and able to ... more
- Gilead Sciences, Inc. (Foster City, CA)
- … Manager , Project Management** **Location: Foster City** **Specific Responsibilities:** The Senior Project Manager in PDM Portfolio Strategy and Operations ... more
- Takeda Pharmaceuticals (Boston, MA)
- …experienced, versatile and strong enterprise leaders + Committed to simultaneously driving regulatory approval as well as launch and global patient access + Ability ... more
- Merck (West Point, PA)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... more
- Mizuho Corporate Bank (New York, NY)
- About the Team The Capital Markets Credit ( CMC ) department at Mizuho Americas consists of team of experienced credit professionals whose primary responsibilities ... more