- Sanofi Group (Morristown, NJ)
- **Job Title:** Head of Global Regulatory Affairs , CMC Small Molecule **Location:** Morristown, NJ **About the job** Join the engine of Sanofi's mission - ... impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a critical… more
- Takeda Pharmaceuticals (Boston, MA)
- …Production, Quality Assurance can be considered. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development ... as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned… 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
- 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
- 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
- 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
- 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
- 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
- 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
- Chiesi (Cary, NC)
- …valuable feedback. Who we are looking for This is what you will do As a Regulatory Affairs Intern within Chiesi Global Rare Diseases, you will gain hands-on ... The internship provides a strong foundation for a future career in regulatory affairs , clinical development, or related functions within the biopharmaceutical… 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
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing ... the company's global regulatory strategy to support clinical development,...activities. Cross-Functional Collaboration * Collaborate closely with Clinical Development, CMC , Medical Affairs , and Commercial teams to… more
- ThermoFisher Scientific (Greenville, NC)
- …company, all while maintaining full-time benefits. **Position Summary** The Director, Clinical Regulatory Affairs serves as a senior regulatory leader ... support timely trial startup and advancement. The Director, Clinical Regulatory Affairs partners closely with Clinical Operations,...and serves as a key point of contact for global regulatory agencies on clinical matters. **Key… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the..., they are responsible for the development of complex global regulatory strategies and preparation of … more
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