- Unknown (Boston, MA)
- … CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC , with experience leading regulatory strategies ... client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations and guidelines… more
- Unknown (Gaithersburg, MD)
- …infectious disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious ... immtav and immtaai About the Role The Company is seeking a Vice President of Regulatory Affairs to lead a team in the development and execution of scientific… more
- Unknown (Gaithersburg, MD)
- …Collaboration with cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs , is essential for the successful development ... is seeking an Executive Director of Process Engineering to lead the design, scale-up, and optimization of cell therapy...GxP compliance, data integrity, and a diversified experience in CMC development for cell therapeutics are also required. The… more
- Unknown (Portland, OR)
- …infectious disease oncology immtacs immune system hiring biologics autoimmune jobs scientists regulatory affairs and cmc biotechnology cancer infectious ... of high-value business relationships. The Vice President will be expected to lead a small team, collaborate with various internal functions, and represent the… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... States regulatory frameworks and global CMC strategy. This role will lead the...MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... through strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant...(NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + … more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... guidance, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC ...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… more
