- Lilly (Indianapolis, IN)
- …and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and ... need them all over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial...Products to be a part of the Lilly post-approval regulatory group to support global submissions and… more
- Organon & Co. (Plymouth Meeting, PA)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals...will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise… 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 ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... scientist will be encouraged to demonstrate innovative regulatory strategies that support the lifecycle of… more
- Organon & Co. (Jersey City, NJ)
- …+ Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, ... strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes… more
- ThermoFisher Scientific (Boston, MA)
- …activities. + Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate ... company, all while maintaining full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a Distinguished Scientist , CMC Team Leader, Proteins to be...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a** **Distinguished Scientist , CMC Team Leader, Protein Conjugates** **to...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- Astellas Pharma (South San Francisco, CA)
- ** Scientist II, Bioassay & Research** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... For more information, please visit our website: www.astellasgenetherapies.com. **The Role:** The Scientist II will take a lead in developing and transferring assays… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... scientist will be expected to demonstrate innovative regulatory strategies that support the lifecycle of… more
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