- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… 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 ... 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
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... 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
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life 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… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their ... team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead ... an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The...summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO ... and other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development to post-authorization… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on ... Senior RA Specialist will also support related regulatory affairs activities, such as development, execution...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… more