- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... drug approvals through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC… 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)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... 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… more
- Lilly (Indianapolis, IN)
- …need 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
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... department. Leads initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with other functional areas to drive… more
- 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 our ... in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and provide … more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health Authorities. +… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Organon & Co. (Jersey City, NJ)
- …for the preparation and review of information required for development of regulatory CMC dossiers for commercial products. Primary responsibilities include, but ... across the product lifecycle + Identify and communicate potential regulatory issues to Organon Regulatory CMC management, as needed. Technical Skills +… more
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