- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence function, responsible for driving... Affairs, as well as cross-functional stakeholders (eg, RA CMC , R&D Excellence, Clinical Operations, IT).Responsibilities Operate within and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Works with manager to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to maintain surveillance of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director.… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Aequor (NJ)
- …and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, IRT Organizations, and ... 100 % remote Manager prefers local candidates (will consider non local...phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs, CMC , New Products, Sales & Marketing, and Legal ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Axelon Services Corporation (Atlanta, GA)
- …Monitoring ( GSMM ), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC , QA, Packaging Vendors, CRO's, IRT Organizations, and Global ... studies during phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery of supplies to… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... overarching and competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound. That strategy will… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Job DescriptionThe drug development Project Manager is part of Global Project and Alliance...our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development… 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 ... focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a typical day might include the following: +… more
- 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
- J&J Family of Companies (Raritan, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager , CMC ... to these teams and global regulatory teams. + Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs, therapeutic… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the ... following requirements: Master's degree in Regulatory Affairs or related field plus 2 years of...of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... timely manner + Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to...to support their development + May serve as direct/matrix manager of RAV CMC staff, depending on… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the… more
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