- 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. (Jersey City, NJ)
- **Job Description** **The Position** The Sr. Scientist , Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ) ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products...strategies by leading the development, authoring and review of CMC submission components and documentation to support … 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
- Merck (North Wales, PA)
- …in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where drug is the primary mode of action ... Associate Director position. Under direction from a Director, the Associate Principal Scientist is responsible for implementing regulatory strategies for our… more
- Eurofins (Indianapolis, IN)
- …product submissions across geographies, with support or guidance from Client GRA- CMC regulatory scientists. + Provide high quality, timely and clear ... develop successful regulatory strategies and submissions in support of clinical trials. This position utilizes CMC...Optional: + Three or more years of direct global regulatory CMC experience, or equivalent experience supporting… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly… more
- Cardinal Health (Hartford, CT)
- … Regulatory Science clients. Working remotely under the supervision of the CMC Supervisor, the Scientist I builds and formats Common Technical Documents ... to Cardinal Health_** The _Scientist I, Chemistry, Manufacturing, and Control ( CMC )_ ensures efficient and quality production of product submission dossiers for… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** Join as a Digital CMC Scientist to support the planning, development and execution of the ... this role, you will work closely with the Sustainable CMC and Innovation team as well as capability leads...workflows, and best practices in an environment where formalized regulatory guidance is still evolving. You will play a… more
- Lilly (Indianapolis, IN)
- …life-changing new medicines to patients who need them all over the world. We are seeking Regulatory Scientist GRA- CMC to be a part of the Lilly global ... support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory ...The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage… 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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