- Regeneron Pharmaceuticals (Troy, NY)
- The Manager , CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple ... clinical programs and/or submissions. As a Manager , CMC Regulatory Sciences , a typical day might include the following: + Managing and developing CMC… more
- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory ... particular focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences , a typical day might include the… more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible for ... Manager , CMC Regulatory Affairs... Manager , CMC Regulatory Affairs - Remote OR...(MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science , MBA, or MD) + Minimum 7 years of… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant experience + … more
- Pfizer (Andover, MA)
- …Sciences , Business Units, etc. + Serve as a Global Regulatory Sciences Chemistry Manufacturing and Controls ( CMC ) strategist and project leader, providing ... pending registrations and respond to queries. As a Senior Manager , your advanced knowledge of the principles and concepts... Chemistry Manufacturing and Controls ( CMC ) or regulatory expertise in pharmaceutical science development and/or… more
- Merck (Rahway, NJ)
- …analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies. + May participate with manager in discussions ... **Job Description** In BARDS (Biostatistics and Research Decision Sciences ), a distinguished department within our company's renowned Research and Development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Manager , Global External Manufacturing Oral-Solid Dosage (OSD) works to ensure ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by ... supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more