- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC technical ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... CMC development of peptides and sterile injectables. This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- Lilly (Indianapolis, IN)
- …all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, ... Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of experience in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + ... **1. Strategy and Roadmap Development** + Define and continuously refine a CMC RA Digital Enablement roadmap aligned to organizational priorities and enterprise… more
- Boehringer Ingelheim (Athens, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Pharma Product Group Associate Director will be fully accountable for providing CMC leadership and… more