- 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 ... Physical Requirements Percentage of Travel: 10%. Qualifications Education: BS degree in a science discipline. Advanced degree in the Life Sciences or related… 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Regulatory Affairs (GRA) Process Excellence function, responsible for driving… 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
- 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
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late… 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
- 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 - West Chester,...(MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science , MBA, or MD) + Minimum 7 years of… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Associate Director** **; CMC , Device Development Program Manager ** **Functional Area: Technical Operations** At ... to each other, and trust in ourselves and our science . This is a matrix leadership role that collaborates...collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... Requirements Percentage of Travel: 10%. Qualifications + Education: BS degree in a science discipline. Advanced degree in the Life Sciences or related field… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...to impact the lives of patients while conducting cutting-edge science . There are short communication lines across the company,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …impact. Join Gilead and help create possible, together. **Job Description** Gilead Sciences , Inc. is a biopharmaceutical company that has pursued and achieved ... 35 countries worldwide, with headquarters in Foster City, California. ** Manager , Global External Manufacturing, Small Molecule Drug Substance** **KEY… 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)
- …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
- 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 ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of ... relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team… more
- LA Care Health Plan (Los Angeles, CA)
- Financial Compliance Data Manager II Job Category: Accounting/Finance Department: Financial Compliance Location: Los Angeles, CA, US, 90017 Position Type: Full Time ... net required to achieve that purpose. Job Summary The Financial Compliance Data Manager II is responsible for providing assistance and support to the Claims… more
- Taiho Oncology (Princeton, NJ)
- …Liaises with CMOs to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/ Regulatory / CMC to set specifications, and ... Sr. Manager , Analytical Development Princeton, NJ, USA Req #362...and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a… more
- WuXi AppTec (Middletown, DE)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
