- J&J Family of Companies (Horsham, PA)
- …located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of ... CMC regulatory professionals and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for innovative… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of ... marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as primary internal contact for all US regulatory… more
- Insight Global (Summit, NJ)
- Job Description Insight Global is looking for a CMC Regulatory Consultant to join the Regulatory Affairs organization within R&D at a Consumer Healthcare ... organization. This individual will be responsible for authoring, reviewing, and approving regulatory documents and submissions within Module 2 and Module 3. They… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Lilly (Indianapolis, IN)
- …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 ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Lilly (Indianapolis, IN)
- …that 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 ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… 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)
- …manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory ... + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, acquiring… more