- 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. (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
- 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
- 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, ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound.… 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …etc. with minimal guidance. + Leads the planning, logistics, and scheduling for CMC Regulatory Affairs Leadership Team meetings and any other similar leadership ... manage managers calendar's (including Pharmaceutical Development & Manufacturing Leadership Team, CMC Regulatory Affairs Leadership Team OOO calendars) + Assists… 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
- 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
- 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
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job ... Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job Summary:**...+ Serve as the QA point of contact in CMC and Process Development and direct QA functional areas… 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
