- 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 ... responsible/accountable for: RESPONSIBILITIES Planning, preparation and submission of global regulatory CMC -related content pertaining to clinical trial… 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 ... or all CMC operations across Regeneron. As a Senior Manager of CMC Industry and Regulatory Intelligence, a typical day might include the following:… 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 ... FDA) regarding CMC matters. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages...position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based… 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 ... Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial… 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 ... new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager , Analytical Sciences Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology company ... from immunological diseases. Position Summary: We are seeking a Senior Manager , Analytical Sciences to join an...CMC team and key personnel including Quality Assurance, Regulatory , and Project Management, and with external CDMO and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… 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 ... but not limited to, Clinical Operations, Chemistry, Manufacturing and Controls ( CMC ), Product Quality Assurance (PQA), Regulatory Affairs and Sourcing… 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 ... team for Integra's Collagen Manufacturing Center ( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The PDS&T Program Manager is an experienced leader responsible for managing large global projects ... products by integrating the efforts of R&D, S&T, Quality, Supply Chain, Regulatory . After product launch, this individual is responsible for managing the capacity… more