- Merck & Co. (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of… 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
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... reporting, & overall first level of project guidance. Relationships Reports into Director , CMC Program Development. Essential Functions Project Management Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biologics and Oncology, incl. coordinating Reg Intelligence & Policy activities with the Regulatory - CMC function and corporate affairs as needed. In the short ... is compatible with DS' strategic objectivesWork with other DS functions (incl. Regulatory - CMC ) to coordinate Regulatory Intelligence activities and ensure… more
- Merck & Co. (Rahway, NJ)
- …across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality, Regulatory CMC , and technical functions, to ensure timebound ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… 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
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director , Toxicology is a key member of the nonclinical safety team, reporting… more
- Merck & Co. (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent ... functional groups in development, quality, safety, facilities management, analytical, finance and regulatory .-FLEx was designed to be a facility that evolves to meet… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Merck & Co. (North Wales, PA)
- …that facilities/processes are compliant and support approval of new modality regulatory filings.our Technical CMC teams for end-to-end Quality oversight/support ... System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other worldwide… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …understanding of Pharma or life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy ... Position Summary The Director of Project Management will lead a team of project management professionals ensure projects are executed effectively and efficiently… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions The… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… 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
- Taiho Oncology (Pleasanton, CA)
- …Value Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive ... Director , Regulatory Affairs CMC Pleasanton, CA, USA...Director , Regulatory CMC . Your expertise will play a pivotal and visible role in advancing… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Apr 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help develop … more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli ... them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical knowledge and … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory … more
