- 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
- 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
- AbbVie (Florham Park, NJ)
- …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
- 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
- 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
- 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
- Sanofi Group (Waltham, MA)
- …CMC dossiers. The CMC Dossier Sciences department within Sanofi R&D Global CMC Development organization has critical roles and responsibilities in leading ... the preparation of CMC dossiers for regulatory submissions to enable...Experience with emerging digital technologies in pharmaceutical development and/or regulatory affairs + Skilled in AI applications… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product /… more
- Lilly (Indianapolis, IN)
- …with analytical R&D, process development, manufacturing science, quality, and regulatory affairs to standardize data products. **Deliverables include:** ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late ... **The Experts at Hiring Experts.** **Title:** Vice President/Senior Vice President, Global Regulatory Affairs **Pay:** $300,000-$400,000 per year,… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sumitomo Pharma (Lincoln, NE)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Bausch + Lomb (Trenton, NJ)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing ... in the four domains of Regulatory , Chemistry Manufacturing and Controls ( CMC ), and Global Health Integrated Development Expertise (GHIDE), which includes… more
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