- Actalent (Boston, MA)
- …a creative and agile regulatory professional eager to join a collaborative team as a Director / Sr . Director of Regulatory CMC based in Boston with a hybrid ... Job Title: Director Regulatory CMC Job Description We are seeking...8+ years of experience in CMC Regulatory Affairs for biologics , including IND activity, global CTAs, DSURs, and agency… more
- Charles River Laboratories (Wilmington, MA)
- …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... you build a career that you can feel passionate about. **Job Summary** The Director of Global Sales for our Next-Generation Sequencing (NGS) business will lead a… more
- Sanofi Group (Morristown, NJ)
- …the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. + Primary Liaison with ... **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location**...monitoring and updating of standards and processes related to drug , device, and biologics US AdPromo regulations… more
- Regeneron Pharmaceuticals (Hawthorne, NY)
- We are currently seeking an established leader and drug hunter for the R&D (Research & Development) Chemistry group. In this position, they will play a key role in ... expanding the Regeneron small molecule and peptidomimetic antibody-conjugate drug discovery capabilities, while providing innovation and leadership to seamlessly… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Business Unit Summary** Our Drug Product Development team is committed to CMC design, development, and ... commercialization of innovative drug products to improve patient lives. We leverage the...are seeking an experienced and highly motivated Associate Scientific Director to join the Integrated Technology and Engineering group… more
- AbbVie (Waltham, MA)
- …of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business ... regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers,… more
- Alloy Therapeutics (Waltham, MA)
- …capabilities that are foundational for discovering and developing therapeutic biologics . The company facilitates affordable, non-exclusive access to the entire ... drug discovery community from academic scientists, small and medium...our affiliated venture studio, 82VS. The Role The Associate Director , Strategic Initiatives and Business Operations is a versatile… more
- BeOne Medicines (San Mateo, CA)
- …Affairs with the FDA and prior experience with both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical ... **General Description:** The Director , Regulatory Affairs will be responsible for developing,...Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and… more
- Catalent Pharma Solutions (Morrisville, NC)
- ** Director , Business Development, Nasal Delivery** **Position Summary** Catalent is a global leader in providing integrated services, superior delivery technologies ... help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. (https://www.catalent.com/about-us/overview) It is an… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... regarding global development, regulatory, and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more