- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- AbbVie (Waltham, MA)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... ADC, and/or cell/gene therapy is particularly beneficial. Responsibilities + Prepares CMC regulatory product strategies. Prepares and manages regulatory… more
- 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
- 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
- Deloitte (Boston, MA)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML,… more
- ThermoFisher Scientific (Boston, MA)
- …full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for late-stage and commercial programs in analytical ... CMC areas (eg, registrational CQAs, control strategy, justification of...Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate cross-functionally with… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- In this key leadership role, you will build and oversee Global Regulatory Science and Regulatory CMC strategic framework and will support driving ... regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and play a critical role… more
- Sanofi Group (Framingham, MA)
- …development and developability activities. Contribute to the authoring and review of CMC regulatory filings and responses to information requests. + Maintain ... be able to play a key role in supporting CMC biologics development at Sanofi. The Director of the...scientific team and oversee characterization studies in line with regulatory expectations for biologics for all phases of development.… more
- Sanofi Group (Cambridge, MA)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Bayer (Cambridge, MA)
- …+ Deep understanding of Pharmaceutical R&D business processes (preclinical, Clinical, CMC , Regulatory , PV) and underlying data, procedures, policies and ... to R&D data management with an initial specific focus on product and regulatory data. This role has broad accountabilities for the following 1. Regulatory… more