- 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)
- …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 (Athens, 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
- Astellas Pharma (Northbrook, IL)
- …Regulatory Affairs , Quality Assurance, Business Partners). Responsible for developing regional/ global CMC regulatory strategy (eg, CMC ... apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with...**Responsibilities and Accountabilities:** **Strategic Leadership:** + Define and implement global CMC regulatory strategies with… more
- Taiho Oncology (Princeton, NJ)
- …and enhance your skills. Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned ... an agreed upon plan. Performance Objectives: + Independently develops global regulatory CMC Strategies and...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… 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
- Parexel (Frankfort, KY)
- …and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan ... CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as..., Project Management). + 3+ years proven experience in regulatory affairs , particularly in CMC … 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...in initiatives internal to RA CMC . Represents CMC regulatory affairs on project… more