- 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
- Merck (Boston, MA)
- … updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory ... Pharmaceutical Process Development, Procurement, Regulations, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory… 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to… 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
- ThermoFisher Scientific (Cambridge, MA)
- …people and communities depend on - now and in the future. **Position:** Associate Director /Senior Project Manager, Drug Development, FSP Location: Remote, US ... Project Management skills + Must understand pre-clinical drug development activities, CMC , regulatory and commercial activities + Translate strategic plans… 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