- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Manager , Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs ... Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure internal processes… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Sr. Manager , GMP Quality Assurance is responsible for ensuring that all GMP-regulated ... distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role ... OverviewThe MES Project Manager will be part of Manufacturing Science and Technology...Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC , and IT. This individual will be responsible for… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… 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
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team....be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- Bristol Myers Squibb (Indianapolis, IN)
- …external stakeholders . Review and author technical reports and source documents to support regulatory filing. . Review and author CMC sections for IND/NDA for ... critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls ( CMC ) strategy and ensuring successful technology transfer to clinical and… more
Related Job Searches:
Associate Manager CMC Regulatory,
CMC,
CMC Manager,
CMC Regulatory,
Manager,
Manager Regulatory Affairs CMC,
Regulatory,
Regulatory Manager,
Senior Manager CMC Regulatory,
Sr Manager Regulatory CMC