- Gilead Sciences, Inc. (Foster City, CA)
- …serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory ... portfolio. This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- Takeda Pharmaceuticals (Lexington, MA)
- …This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical ... follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project ... **Job Description** + Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances,… more
- Lilly (Indianapolis, IN)
- …the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing life-changing new medicines ... over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial Products to be a part of the...you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support… more
- Lilly (Indianapolis, IN)
- …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 who ... Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical...Affairs - CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- Sanofi Group (Framingham, MA)
- **Job Title:** CMC Project Manager **Location:** Framingham, MA, Waltham, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed ... be critical in helping our teams accelerate progress. The CMC Project Manager is a key contributor of the... Project Manager is a key contributor of the CMC Project Excellence department to provide a world class… more
- Eurofins (Indianapolis, IN)
- …strategies and submissions in support of clinical trials. This position utilizes CMC technical knowledge to drive internal consistency and influence effective change ... not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive role in the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for providing strategic ... direction, tactical support, and technical expertise for CMC regulatory activities and related regulatory initiatives. + Responsible for guiding and overseeing the… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a hybrid role within CMC ... functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change management, and...Manager is responsible for CMC regulatory operations, CMC change management, and document lifecycle management within IMP… more
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