- Takeda Pharmaceuticals (Boston, MA)
- …requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market ... and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global… more
- Sanofi Group (Framingham, MA)
- …possible. Ready to get started? **Main Responsibilities:** **Develop and implement global regulatory CMC strategies** + Create strategies for development and ... CMC documentation and submissions** + Write, prepare, review, and approve regulatory CMC dossiers + Ensure dossiers meet quality standards + Comply with … more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC ... with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development/due diligence… more
- Sanofi Group (Framingham, MA)
- …was possible. Ready to get started? **Main Responsibilities:** + Develop global regulatory CMC strategies and risk assessments for development projects and/or ... that impact the company + Identify, communicate, and manage resolution to routine/complex regulatory CMC issues. Articulate the implication of issue to project… more
- Sanofi Group (Framingham, MA)
- …Leader leads a cross-functional CMC team with representatives from CMC Development, Manufacturing and Supply, Quality, Dossiers, Regulatory , Demand and ... the CMC contributions to pre-clinical, clinical and validation (DS/DP), and CMC elements for regulatory submissions and consultations. + He/she evaluates the… more
- Bausch + Lomb (Boston, MA)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
- Bausch + Lomb (Boston, MA)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management… 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
- 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
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