- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products ... - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in...regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division / our Research & Development Division ) such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... Leadership, Pharmaceutical Development, Pharmaceutical Formulations, Pharmaceutical Sciences, Product Development, Regulatory CMC , Statistical Design of Experiments (DOE),… more
- Formation Bio (New York, NY)
- … leaders.Responsibilities Strategic Leadership Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products, ... & External Partnerships Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...as well as supply chain documentation to support critical CMC activities. - - Support the collection of clinical… 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. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Eisai, Inc (Exton, PA)
- …as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations ... If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a… more
- Organon (Plymouth Meeting, PA)
- …Scientist (Associate Director ) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned ... across the product lifecycle Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed Required Education,… more
- Olema Oncology (San Francisco, CA)
- …feel better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, ... closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory , Clinical Supply and CMC teams Develop and implement… more
- Commercial Metals Company (Irving, TX)
- …and systems of each business unit Ensure all financial practices comply with CMC Policies and regulatory requirements across all lines of business ensuring ... it's what's inside that counts There's more to CMC than our products and the buildings, structures,...your role and reach your full potential. As Senior Director of Finance for the Emerging Businesses Group, you… more
- Sutro Biopharma (South San Francisco, CA)
- Description Sutro Biopharma, Inc. is looking for a Director , Regulatory Affairs Medical Writer who will provide leadership in development and execution of ... scientific writing and will work cross-functionally, advising the team on regulatory expectations for document content while maintaining compliance with global (FDA,… more
- Arrowhead Pharmaceuticals (San Diego, CA)
- …develop and execute regulatory plans. This position will report to the Director , Regulatory Affairs and collaborate with regulatory and other departments ... need. The Position This position is responsible for supporting multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements… more
- Clinical Dynamix, Inc. (Florham Park, NJ)
- …filings in a dynamic environment is required. *In-depth knowledge and experience of regulatory CMC documents review, and approval is required. *Provide ... Job Description - AD/Dir Regulatory Affairs Reports To: SR Director - Regulatory Affairs. *Prepare and review various modules of ANDAs, and responses to FDA… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …regulatory guidelines. Collaborate effectively with multidisciplinary teams including clinical, regulatory , nonclinical, and CMC functions to ensure alignment ... visit Acadia.com and follow us on LinkedIn and X. Position Summary The Director of Clinical Pharmacology will play a pivotal role in driving Acadia's early… more
- NWRPros (Brisbane, CA)
- Our client-a clinical-stage genomic medicine company-recently achieved a major regulatory milestone for its lead gene therapy program targeting a rare lysosomal ... submission. A Biologics License Application (BLA) is expected in 2026. Recent regulatory meetings have also clarified the Chemistry, Manufacturing, and Controls. Our… more
- MannKind Corporation (Bedford, MA)
- …voice matters and every contribution counts. Position Summary: We are seeking an Executive Director of Pharmacology to join our R&D team. This role will support our ... scientific approaches with business objectives. Partner with clinical and regulatory teams to design and support clinical studies with...on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.… more
- Healthcare Staffing Plus (Missoula, MT)
- …as stroke, traumatic brain injury, and severe burns. POSITION SUMMARY The Director of the Laboratory is a qualified professional with appropriate clinical training ... for the overall operations of laboratory services in the medical center. The Director is responsible for all personnel, budget, planning, capital equipment and … more
- Dyne Therapeutics (Waltham, MA)
- …current planning activities and shaping future supply chain capabilities. The Director collaborates cross-functionally with Process Development, Research, CMC , ... and follow us on X, LinkedIn and Facebook. Role Summary: The Director of Supply Chain Planning is responsible for end-to-end inventory and production… more
- Lifelancer (London, KY)
- … interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs, Program Management, CMC , and external CROs ... About the job Sr Medical Director Job Title: Sr Medical Director ...oversee medical aspects of clinical trials from design to regulatory submission, providing scientific and operational leadership in close… more
