- System One (New Brunswick, NJ)
- …candidates should have at least 2 years of experience specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry. ... sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high… more
- AbbVie (North Chicago, IL)
- …as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing ... is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation,… more
- Sanofi Group (Framingham, MA)
- …and CMC requirements. The role will provide scientific expertise supporting CMC regulatory guidance with innovative approaches to process and analytical ... global CMC projects. + 5+ years of experience with CMC regulatory guidance specific to process/analytical comparability and health authority submissions. +… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and analytical testing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- Orchard Therapeutics (Boston, MA)
- …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... in the technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. . Recent experience in the preparation… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …of drug candidates through appropriate formulation strategies. + Support preparation of CMC regulatory documents. + Support departmental initiatives for assigned ... approaches, and cGMP principles. + Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Basic… more
- Sanofi Group (Cambridge, MA)
- …+ Ensure good communication and cooperation among different functional groups, including CMC Dossier, Regulatory CMC , Research Platform, and Manufacturing ... Ability to operate independently and to prioritize + Familiarity with cGMP and regulatory requirements on analytical methods + Prior CMC project management… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more