of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient... based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval...
Job Description General Summary: The Associate Director, CMC Regulatory Affairs, Biologics executes multi-product... global regulatory CMC strategies for investigational and marketed products, with a focus on biologics. This role leads the...
Job Description The Senior Director, CMC Product Leader, Biologics, will lead CMC functional teams of one or multiple... Compliance and Quality Assurance: Develop CMC regulatory strategies and lead the preparation of CMC sections for regulatory...
: As a CMC Lead, Small Molecules (Associate Director), you will be responsible for leading and managing the engineering... to CMC Leads to drive effective life cycle management for Takeda’s commercial small molecule portfolio. Provide...
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...
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...
, and innovative Associate Director specializing in analytical CMC strategy to provide scientific leadership... within and across functional areas. The Associate Director, Analytical CMC Strategy is the primary analytical liaison for their program...
, analytical development, manufacturing science and technology, site QA/QC, and regulatory CMC and commercial functions (i.e., AS&T..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
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...