- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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
- 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
- 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
- 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, ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… 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) ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
- Aequor (Thousand Oaks, CA)
- …small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management ... chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product Quality… more
- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …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 Gilead's global portfolio of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for ... 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
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The CMC Regulatory Associate Director , Biologics is responsible for content ... aspects of global change management. **Position Summary / Objective** The CMC Regulatory Associate Director , Biologics is responsible for content… 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 ... policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… 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. ... Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- AbbVie (North Chicago, IL)
- … CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Must possess good scientific writing ... matrix management approach; Key member of Asset Strategy Team (AST) and ensures CMC strategy is closely aligned with the clinical and regulatory development… more
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Multiple product development experiences… more
- BeiGene (Emeryville, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… more
- AbbVie (North Chicago, IL)
- …issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… more
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