- 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 (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
- 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
- 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