- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and...leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC… more
- ADM (Chicago, IL)
- **96226BR** **Job Title:** Senior Director of Regulatory & Scientific Affairs , Health & Wellness **Department/Function:** Research & Development **Job ... Description:** ** Senior Director , Regulatory and Scientific Affairs , Health & Wellness - Chicago, IL; Decatur, IL; Kennesaw, GA; or Erlanger, KY**… more
- Mohawk Valley Health System (Utica, NY)
- Sr Director Quality Management & Regulatory Affairs - Full Time - Days Department: QUALITY IMPROVEMENT Job Summary The Senior Director of Quality ... and regulatory operations throughout the organization. The Senior Director of Quality Management Systems &... Director of Quality Management Systems & Regulatory Affairs is accountable for developing, leading,… more
- Lilly (Indianapolis, IN)
- …the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises expertise in the ... degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas of at least 14… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and leads global ... draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior...Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual ... in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC-related regulatory submissions and… more
- ConvaTec (Lexington, MA)
- …of a small team. Reporting to Senior Manager - International Regulatory Affairs , additional direction from Sr . Director , Regulatory Affairs ... responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst...initial expected outlay must be discussed and agreed by Senior Manager, or higher prior to execution. **Skills &… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of...technical success for the mitigation strategies proposed. + The Sr Director / Director will be accountable… more
- Organon & Co. (Jersey City, NJ)
- …Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director or Director , Global Therapeutic Area ... Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new legislations, guidelines and… more
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