- 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. (Lansing, MI)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Parexel (Providence, RI)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Gilead Sciences, Inc. (Washington, DC)
- …A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC ... Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused...PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative… more
- Boehringer Ingelheim (Duluth, GA)
- …product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical biotech and ... Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...initiatives internal to RA CMC . + Represents CMC regulatory affairs on project… more
- Organon & Co. (Jersey City, NJ)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is...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)
- …Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …quality principles, and regulatory expectations to support relevant global regulatory submissions. + Authors, reviews and edits CMC sections and provides ... functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC...considerations via risk-based approaches. + Continually monitors the evolving global regulatory landscape regarding CMC … more