- Aequor (Thousand Oaks, CA)
- …and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions. Tasks ... job description and be able to speak to why they want to work in regulatory affairs/ CMC . This was a big miss on the last posting. Pre screening responses from… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process and analytical development, technology transfer, process comparability and qualification, CMC regulatory guidelines, process monitoring and analytics and ... science, or related field Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive… more
- Lundbeck (Bothell, WA)
- …and represent the Potency team as needed Assist in the preparation of CMC regulatory submissions including authoring and/or review REQUIRED EDUCATION, EXPERIENCE ... Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019,...to the position is a thorough understanding of the regulatory and industry standards that are required for potency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early ... serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or New Modality) team.- Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses ... (mAb, Drug Substance, Drug Product, or New Modality) manufacturing, evaluates CMC risks for appropriate escalation, recommends transition milestones and ensures a… more
- Aequor (Thousand Oaks, CA)
- …small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management ... executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory , Process Development, Quality Assurance, and other functional areas… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing ... Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and… more
- Aequor (Seattle, WA)
- …clear communication and collaboration across all involved teams. Ensure compliance with regulatory requirements and industry standards in all CMC activities. The ... etc. Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC analytical method development & transfer. Job DescriptionThe Technical… more
- Merck & Co. (Rahway, NJ)
- …areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
- Merck & Co. (Rahway, NJ)
- …work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs- CMC to ensure that validated methods are appropriately transferred from ... issue management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory submission… more
- Aequor (Thousand Oaks, CA)
- …just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration by developing and ... executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Title: … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes defining regulatory data standards, data quality… 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) ... as applicable to the project.Building and maintaining project schedules and critical project information in enterprise project management systems and databases. Using these tools to integrate activities across key team members, proactively identify risks, and… more
- Catalent (St. Petersburg, FL)
- …to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings.Catalent is committed ... to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The RoleAnalysis of finished products, in-process materials, fill moisture, raw materials, and cleaning verification and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …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 Gilead's global portfolio of small… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix ... a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as… 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 professional ... rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager, CMC Regulatory Sciences, a typical day might include the following: + Develop… 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, ... for meetings with global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be for you if you have: + Excellent… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + Demonstrates success in influencing without… more
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