- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP relevant activities involving but not limited to supplier qualification program, CMC audit, clinical/IMP vendor audits and overall GMP vendor audit program. ... readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or...order to ensure the inspection readiness level of each site and maintain a capacitation program for GMP staff… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position Oversee the CMC QA Organization for the site , which includes responsibility for the Quality ... includes ensuring the quality goals align to the respective site 's goals Meet or exceed business, regulatory ...respective site 's goals Meet or exceed business, regulatory & internal customer requirements in accordance with Novo… more
- Takeda Pharmaceuticals (Boston, MA)
- …of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant ... based on risk and scientific rationale. + Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... **Overview** The Director , CMC provides leadership for the...of regulatory submissions. + Experience with complex CMC regulatory submissions for both development and… 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
- 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 stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities… 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
- 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
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
