- Gilead Sciences, Inc. (Foster City, CA)
- …operates in more than 35 countries worldwide, with headquarters in Foster City, California. ** Sr Director , CMC Regulatory Affairs -Small Molecules** ... **KEY RESPONSIBILITIES** The Sr Director , CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide...operate" by maintaining the global licensures. In addition, the Sr Director will be accountable for leading… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...of related experience regulated industry or health authority + Senior Director : 20+ years of related experience… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC ...Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is ... analytical methods, formulation development, manufacturing, and labeling. The Sr Director , Regulatory Affairs CMC is also responsible for the oversight… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule where you ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC , you will be responsible ... activities related to the resolution of requests from the regulatory agencies. + Function as the CMC ...ability to inspire and motivate direct reports at the director level and below. + Ability to work independently… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... within overall CMC development project(s), to support Sr CMC Lead. In case no ...- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or… more
- Sanofi Group (Framingham, MA)
- …to process development activities. + Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding ... discovery and development to find answers for patients and their families. The CMC -Biologics Statistics team is seeking an expert data scientist / Statistician to… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Launch Readiness - Immunology Date: Jun 23, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... messaging, positioning, creative campaign development and regional alignment/coordination). The Senior Director , Global Launch Readiness Immunology will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... stakeholders. Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development, Supply Chain and other… more
- Gilead Sciences, Inc. (Foster City, CA)
- …headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director , Analytical ... to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …managers, medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). **A ... The ** Sr Manager, Clinical Drug Supply & Logistics** is...IP expiry. + Coordinates with other functional areas, including Regulatory , Medical Director , Forecasting & Planning, and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical, may be called ... plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs -...support marketing product claims. + Acts as liaison between Regulatory Affairs & CMC and other functional… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio ... be responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
- Integra LifeSciences (Plainsboro, NJ)
- … agencies. **SUPERVISION RECEIVED** Receives minimal supervision from the Director , CMC Quality Operations. **SUPERVISION EXERCISED** Manages personnel ... system requirements and how they impact product quality and regulatory compliance. + Works with Senior Management...quality and regulatory compliance. + Works with Senior Management to achieve alignment of Quality Goals and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director , Commercial Regulatory Affairs, is responsible for the ... marketed products in US and Canada. In addition, the Senior Director , Commercial Regulatory Affairs,...Commercial Regulatory Affairs, in collaboration with Head, Regulatory Affairs and CMC -RA, will review and… more
- Editas Medicine (Cambridge, MA)
- …and distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr . Director , Supply Chain, you will be responsible for: + Building ... and Technical Operations and partner with leadership in TechOps, ClinOps, Finance, CMC and Program Teams to lead short-term integrated production and raw materials… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Purification Process Development - Pivotal & Commercial ... Biologics** The Senior Director of Purification Process Development for...strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC , and Manufacturing. + Lead… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory policies and ... The Director , Regulatory Affairs will be responsible...Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC … more