- Sanofi Group (Swiftwater, PA)
- **Job Title:** Manager, Global Regulatory Affairs - CMC - Vaccines **Location** : Swiftwater, PA or Morristown, PA **About the Job** Are you ready to ... critical in helping our teams accelerate progress. The Manager, Global Regulatory Affairs - CMC has the responsibility of one or several… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials,… more
- Lilly (Indianapolis, IN)
- …market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines for obtaining global product… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
- Sanofi Group (Morristown, NJ)
- …development and marketed product objectives. + Represent GRA CMC on GRAT ( Global Regulatory Affairs Team) + Assures effective involvement with change ... The team responsibilities include but are not limited to: global regulatory CMC strategies, submission...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …years) required. + Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global ... + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for...CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to… more
- Lilly (Indianapolis, IN)
- …+ Deep technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug ... knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for... global regulatory expectations + Provide regulatory guidance to allow CMC development teams… more
- Merck (Rahway, NJ)
- …a chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing ... CMC regulatory submission strategies and timelines for...organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification,… more
- Lilly (Carolina, PR)
- …world. The Sr. Principal Scientist **or** Advisor Post Approval Scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC ... serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics...+ Lead the execution and influence the development of global CMC regulatory strategies, including… more
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