- 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 (Emeryville, 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
- 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
- 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
- Bristol Myers Squibb (Indianapolis, IN)
- …and external stakeholders . Author technical reports and source documents to support regulatory filing. . Author CMC sections for IND/NDA for FDA submissions, ... to shaping and advancing our Chemistry, Manufacturing, and Controls ( CMC ) strategy **Job Responsibilities** Essential duties and responsibilities include the… 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
- 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
- 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 (Jacksboro, TX)
- CMC Medication Aide Student Trainee - Lindsey Unit **Jacksboro, Texas, United States** Allied Health UTMB Health Requisition # 2506164 The mission of Correctional ... + 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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key member of the GRSP ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… 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
- Parexel (Des Moines, IA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA / Zurich,… more
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