- 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...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: Jun 13, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee and help develop … 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
- 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
- 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… 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
- 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
- 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
- BeiGene (Emeryville, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... functional leadership (including but not limited to clinical Operation, Quality, Regulatory , CMC , and GRDS) to ensure alignment of organizations and prompt… more
- Novo Nordisk (Plainsboro, NJ)
- …this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing… more
- Arvinas (New Haven, CT)
- …For more information, please visit www.arvinas.com . **Position Summary** The Executive Director , Global Regulatory Strategy is responsible for designing and ... knowledge, and interpersonal skills are required. This position reports to the Senior Vice President of Regulatory Affairs and can work remotely from… more
- Editas Medicine (Cambridge, MA)
- …distribution of non-GMP materials at all locations. Key Responsibilities: As the Sr. Director , Supply Chain, you will be responsible for: + Building out all aspects ... 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
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director , PDM Product Strategy Leader for Established Products** **KEY ... team leadership in some aspects of pharmaceutical manufacturing, supply chain, quality, CMC regulatory , or process development, or as a member of… more
- Bristol Myers Squibb (Cambridge, MA)
- …and make a difference. As part of the Discovery Biotherapeutics efforts at BMS, the Senior Director of Protein Engineering will play a key role in discovering ... and delivering a first-in-class and best-in-class Biotherapeutics pipeline. The Senior Director , Protein Engineering, will be responsible for leading a team of… more