- Parexel (Boston, MA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... regulatory leads in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and… more
- Merck (Boston, MA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... in business process mapping, gap analysis, and workflow optimization for CMC / regulatory authoring. + Practical knowledge of content models/structured content,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …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
- 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 (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... lifecycle management and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions,… more
- Sanofi Group (Waltham, MA)
- …organization has critical roles and responsibilities in leading the preparation of CMC dossiers for regulatory submissions to enable advancement of company's ... approval of CMC dossiers + Ensure timely delivery of CMC dossier for regulatory submissions (IND/IMPD/CTN/IB/BP, BLA/NDA/MAA/JNDA, Information Requests from… more
- Sumitomo Pharma (Boston, MA)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … 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
- 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
- Merck (Boston, MA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions to install the foundational capabilities needed to… more