- Regeneron Pharmaceuticals (Tarrytown, NY)
- …portfolios assigned. **A typical day may include the following:** + Responsible for CMC product development activities from a regulatory standpoint during early ... submissions and post market requirements for Cell and Gene therapies + Provide regulatory interpretation, position and strategy for global CMC /CP regulatory … more
- AbbVie (North Chicago, IL)
- …(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 strategy… 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 ... the regulatory strategy for an assigned set of commercial products. The CMC Regulatory Senior Manager is responsible for communicating the … more
- Gilead Sciences, Inc. (Foster City, CA)
- …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 for guiding… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory 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 product lead or… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Early-Stage Biologics Development, CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Early-stage Biologics Development, CMC will be… 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 programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Sr. Manager , CTA Regulatory Strategy is responsible for providing critical support in developing global regulatory strategy, planning, and execution of ... and within established budgets + Work collaboratively with members of the global regulatory team (GRL, Clinical Transparency, Medical Writing, GRA- CMC , etc.) to… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager , Process Development, Downstream Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... treatment for patients suffering from immunological diseases. Position Summary: The Senior Manager , Process Development, Downstream will be responsible for… more