clinical protocols, informed consent forms, Investigator's Brochures, CMC, site documentation etc. for regulatory compliance... Operations, reporting to the Director of Regulatory Affairs Operations, you will provide global regulatory operations support...
activities. In partnership with Northeastern University, Takeda is offering a two-year Global Regulatory Affairs- Plasma..., and find out how advancing transformative therapies at Takeda will shape your bright future. Responsibilities · Regulatory...
Global Regulatory Affairs (GRA) fellowship, based in Boston, MA. About Vertex Vertex is a global biotechnology company...(s) will have an opportunity to gain specialized and in-depth training in two distinct areas of GRA, Regulatory Strategy and Global Labeling...
regulatory requirements for clinical stage, biologics and cell and gene therapy products. Authors or reviews CMC sections... plans to address them Experience authoring or overseeing authoring of CMC sections of regulatory documents. Working...
functional groups such as Global Quality, Regulatory CMC etc. Leadership Provide vision and strategy for manufacturing... Director-Process Engineer SM API Process Sci Location: Cambridge, MA (Hybrid) About the role: As an Associate Director...
opportunity assessments: Stand up and manage cross‑functional workstreams (research, clinical, regulatory, CMC, commercial, legal...Job Description General Summary: The External Innovation (EI) Executive Director leads end‑to‑end identification...
to successful IND/IMPD and/or BLA/MAA applications. Authors CMC sections of regulatory submissions. Ensures that all regulated work... authoring CMC sections of regulatory documents. Experience of Regulatory guidelines relevant to biologics development...
with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability... will report directly to the Senior Director, Supply Chain and will be responsible for ensuring that our investigational therapy...
to help grow our research engine. You’ll work shoulder-to-shoulder with the Director of Research and a team of Scientists... for someone who’s ready to dive in and execute in equal measure. This is a full-time, on-site role. WHAT YOU’LL DO (Key...