- 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
- 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 (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at our South San Francisco office. As ... 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)
- …committed to the rapid delivery of safe life-changing therapies. **Job Summary:** Gilead Sciences seeks a Sr. Manager , Quality Assurance, in the Pharmaceutical ... the product/program, and ensures visibility and communication of key project timelines and CMC milestones + Acts in a project manager capacity to ensure:,… 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
- Actalent (Maryland Heights, MO)
- …will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing ... manager is currently managing both the clinical and CMC portions, and they need someone to come in...need experience working with cross functional teams. The Senior Manager of Regulatory Affairs is responsible for… more
- Actalent (Maryland Heights, MO)
- …will rely on the Canadian RA staff for country-specific regulations. The Senior Manager Regulatory Affairs will directly participate in project teams managing ... (Katie) is currently managing both the clinical and CMC portions, and they need someone to come in...need experience working with cross functional teams. The Senior Manager of Regulatory Affairs is responsible for… 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
- Novo Nordisk (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
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …review of documents with impact to Analytical Sciences . + Collaborates with CMC Reg Sci to support regulatory filings + Identifies and implements effective ... to join our QC (Quality Control) AS (Analytical Sciences ) team. The Associate Project Manager -...CMC program meetings as a representative of Analytical Sciences to serve as the primary point of contact… 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
- Integra LifeSciences (Plainsboro, NJ)
- …making headway to help improve outcomes. **SUMMARY** The Reliability Engineering Manager oversees a multidisciplinary team responsible for the technical and ... GMP manufacturing of medical devices at the Collagen Manufacturing Center ( CMC ). This role is also responsible for multidisciplinary process selection, optimization… more
- Astellas Pharma (Sanford, NC)
- …to: Manufacturing, MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences , Regulatory , CMC teams, Facilities, Validation, Supply ... more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their… more