- 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)
- …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 (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
- Rhythm Pharmaceuticals (Boston, MA)
- …experienced and highly motivated individual to join its team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small ... CMC Drug Substance, Supply Chain Management, Quality, and Regulatory Affairs. + Manages and executes activities related to...as required. + Authors and reviews relevant drug product CMC sections for global regulatory submissions (IND/CTA,… more
- Sanofi Group (Cambridge, MA)
- **Job title** : GRA Device Lead ( Associate Director ) **Location:** Cambridge. MA **,** Morristown, NJ **About the Job** Are you ready to shape the future of ... Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.… more
- Sumitomo Pharma (Boston, MA)
- …Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and ... drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… 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
- ThermoFisher Scientific (Devens, MA)
- …across internal and external manufacturing sites. The principal scientist reports to the Associate Director of GBS and is responsible for stability product ... approval of stability protocols, and preparation, review and approval of CMC elements of regulatory filings to support the activities of the Global Biologics… more
- Humana (Boston, MA)
- …operates about 340+ senior focused primary care centers in 15 states. The Regulatory Compliance team that supports the PCO is responsibility to assess, investigate, ... mitigate risks. The Senior Clinical Compliance Professional will support the Director of Compliance, by ensuring compliance with governmental requirements for… more