- Unknown (Boston, MA)
- …and requirements, providing expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence ... The Director will collaborate cross-functionally with internal teams to...collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Director - CMC Regulatory will leverage CMC technical knowledge and ... regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , CMC Modeling & Advanced Statistics** **What you will do** Let's do ... CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic modeling, Bayesian statistics,… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity to lead ... turn the impossible into possible for millions. The Associate Director role is a key leadership role in ...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation ... CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director , ... CMC . Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US,… more
- Boehringer Ingelheim (Duluth, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Scientific Expert CMC is responsible for providing new product ... and priorities in close collaboration with Quality, R&D and Operations/Manufacturing. The Director , Scientific Expert CMC provides subject matter expertise in… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of ... beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... regulatory frameworks and global CMC strategy. This role will lead the development and...Regulatory Affairs department for the Chemistry, Manufacturing and Controls ( CMC ) aspects of regulatory documents and submissions. Responsible for… more
- AbbVie (North Chicago, IL)
- …third parties. The primary function is to ensure consistent preparation of CMC regulatory submission documents of high scientific and technical quality that are ... efficient processes for preparation, review and approval of these CMC sections. Plays a critical role in ensuring that...sections. Plays a critical role in ensuring that the CMC submission strategy is aligned closely with the clinical/regulatory… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring an Executive Director to lead program management for a portfolio of chemistry-based advanced therapies (ADC, siRNA, mRNA, oligonucleotides, conjugates, ... peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory-to enable accelerated development and commercialization of… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring an Executive Director to lead operations and program management for a diverse portfolio of biology-based advanced therapies (AAV, CGT, protein ... group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate with Finance… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- AbbVie (Florham Park, NJ)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) ... apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables. This individual prepares CMC… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... implementing Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule products in accordance with global regulations and guidance,… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director , Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... and lead others through the interdependencies of various functions within the CMC organization Design, plan, organize, analyze, and evaluate key elements of… more
- UTMB Health (Stafford, TX)
- …treatment algorithms and practices. Works under the general direction of the UTMB - CMC , CHS medical director , with extensive latitude for the exercise of ... Staff Psychiatrist, CHS- CMC - CASUAL **Stafford, Texas, United States** Physician UTMB Health Requisition # 2503005 The mission of Correctional Managed Care is to… more
- RWJBarnabas Health (Toms River, NJ)
- …year Location: 99 Highway 37 West, Toms River, NJ 08755 Job Title: Director Location: CMC Support Department Name:Cancer Center Administration Req #:0000204761 ... factors, including the candidate's educational background, skills and professional experience. The Director serves as the site lead for the Cancer Center at… more
- RWJBarnabas Health (Toms River, NJ)
- …Location: 99 Highway 37 West, Toms River, NJ 08755 Job Title: Administrative Director Location: CMC Support Department Name: Administration Req #: 0000225098 ... educational background, skills and professional experience. Job Overview: The Administrative Director for Women's Health Services is the key executive leader across… more
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