- Parexel (Frankfort, KY)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, dedicated ... affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- AbbVie (North Chicago, IL)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. 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...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution ... and technology excellence. + Drive preparation and support of CMC content for regulatory submissions (initial filings,...strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you… more
- UTMB Health (Galveston, TX)
- Cluster Nurse Manager - CMC - Galveston County Jail **Galveston, Texas, United States** Nursing & Care Management UTMB Health Requisition # 2505552 The mission ... formulation and management. + Ensures facility compliance with institutional, professional, regulatory , and governmental standards. + Assures that all staff are… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care Apply Now **Mission Statement** Michigan Medicine improves the health of patients, populations, ... process and strives to meet budgetary expectations. Actively participates in regulatory compliance activities. + Coordinates use of exam/procedure room space.… 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
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring a Vice President to lead our CMC Program Management team. This position addresses a critical organizational challenge: coordinating Chemistry ... Manufacturing and Controls ( CMC ) activities across 80+ simultaneous programs within a rapidly...+ Cross-Functional Collaboration + Facilitate integration across R&D, manufacturing, regulatory , and quality teams to ensure alignment on timelines,… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physiochemical Testing Date: Dec 14, 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 ... 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
- UTMB Health (Tennessee Colony, TX)
- CMC Medication Aide Student Trainee - Michael Unit **Tennessee Colony, Texas, United States** Allied Health UTMB Health Requisition # 2504653 The mission of ... + Assists with patient activities and care as assigned by the nurse manager /designee as indicated by the patient's plan of care. Maintains patient care areas… more
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This ... plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs, CMC , manufacturing controls, RAC certification, e star,… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Philadelphia, PA)
- …Recruiting for this role ends on 12/20/2025 Work you'll do As a Manager you will lead and deliver engagements, or components of large, complex engagements. ... solutions + 4+ years of experience with Life Sciences Pharmaceutical R&D regulatory data lifecycle . Experience to include introducing new technologies like GenAI,… more
- Takeda Pharmaceuticals (Boston, MA)
- …reports + investigation reports and technical reports supporting submissions + Provide regulatory CMC support by authoring/reviewing drug substance (and relevant ... development and clinical supply processes. + Demonstrated experience authoring CMC sections for regulatory submissions (eg, IND/IMPD/NDA/MAA). +… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …not limited to healthcare antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible for the development of ... requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category...claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for… more
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