- 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 ... your skills. Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate 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… more
- BeOne Medicines (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... Leads the Chemistry, Manufacturing, and Controls ( CMC ) & Combination Products (CP) Internal Medicine team....be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Boehringer Ingelheim (Athens, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... conjugates, peptides). Responsible for end-to-end operational coordination-linking Manufacturing, R&D, CMC , clinical, regulatory -to enable accelerated development and… 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 ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Regeneron Pharmaceuticals (Troy, NY)
- …manufacturing group. + Support data flow and documentation to enable submissions by CMC regulatory teams, ensuring timely and complete packages. + Collaborate ... We are hiring an Executive Director to lead operations and program management for...execution from early development through commercialization, ensuring timely supply, regulatory readiness, and strategic coordination across all technical and… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... and revises policies and procedures in accordance with departmental, hospital, and regulatory standards. . Coordinates review and revision of the Laboratory Test… more
- Atlantic Health System (Pompton Plains, NJ)
- …revision of procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, ... all team members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific enhancements highlighted:… more
- Gilead Sciences, Inc. (Washington, DC)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… more
- Sumitomo Pharma (Lincoln, NE)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Lilly (Indianapolis, IN)
- …drug development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience ... around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory...affiliate requirements. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Regulatory Project Management ( Director , Global RPM) is a senior strategic leader responsible for supporting, ... submissions and ensuring seamless cross-functional integration across regions. The Director , Global RPM proactively anticipates regulatory challenges, influences… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a key ... application should be directed to Chat with Ripley. R1596806 : Senior Director , Global Regulatory Lead Neuroscience **Company:** Bristol-Myers Squibb **Req… more
- J&J Family of Companies (Spring House, PA)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is a hybrid ... We invite candidates from any location to apply. The Director , Global Regulatory Leader in Global ...Area. Ensure strategies are aligned with portfolio objectives, regional regulatory requirements, CMC considerations, commercial goals, and… more
- ThermoFisher Scientific (Greenville, NC)
- …biopharmaceutical company, all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a senior ... RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners closely with...partners closely with Clinical Operations, Clinical Development, Safety, and CMC leadership and serves as a key point of… more
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