- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission ... position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , GRA CMC Small Molecules where you will oversee ... Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and… more
- Takeda Pharmaceuticals (Boston, MA)
- …for the following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director , Regulatory Data Governance Lead **POSITION ... : Takeda Development Center Americas, Inc. is seeking an Associate Director , Regulatory Data Governance...of regulatory updates on data, coordinating with regulatory teams (eg, submission publishing, CMC , drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …protocols and reports + Authoring, review, approval and management of high-quality global CMC regulatory submissions and timely responses to agency RTQs + ... Must be able to apply product development expertise to CMC sections of the regulatory filings. +...and/or contractors). + Budget management and sign off at Assoc. Director authorization level, CMC -DP strategy development,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to bring Better Health and a Brighter Future to people worldwide. As an Associate Director in Analytical Development, you will lead efforts to develop advanced ... Development, Regulatory , Quality, and external partners (CROs/CDMOs) to achieve CMC objectives and meet program timelines. + Represent Analytical Development on… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Associate Director , Clinical Research, Value & Evidence Generation, US Medical** ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- AbbVie (Worcester, MA)
- …policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and ... Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment Responsibilities + Support… more
- Bristol Myers Squibb (Devens, MA)
- …validation protocols, impact assessments, and risk assessments. + Author or review CMC summaries of validation for worldwide regulatory submissions for ... in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** Director of Validation, Cell Therapy Technical Operations reports to the… more
- AbbVie (Cambridge, MA)
- …to ensure an in-depth understanding of the science behind each of these opportunities. The Associate Director , Search & Evaluation will be a key member of the ... one aspect of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs, Chemistry Manufacturing and Controls ( CMC )). + Experience… more
- Sanofi Group (Framingham, MA)
- …Lead, reports to the Head of AST and is based in Framingham, MA. **Analytical Lead/ Associate Director will:** + Serve as the primary contact for assigned product ... with other line functions (within and outside of MSAT, including Quality, Regulatory , CMC /Development) as well as external partners and lead cross-functional… more