- 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
- Merck (Jackson, MS)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... source systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven 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 of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… 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...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- University of Michigan (Brighton, MI)
- Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Early Site Maintenance** We are performing updates and maintenance to our applicant ... employer. **Job Detail** **Job Opening ID** 263624 **Working Title** Medical Assistant Senior ( CMC ) - Brighton Center for Specialty Care **Job Title**… 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 (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… 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
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... antiseptic products. Under the mentorship of the Sr. RA Manager of Regulatory Affairs, they are responsible...required to market medical devices in the US The Senior RA Specialist will also support related regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for… more
- Teva Pharmaceuticals (Weston, FL)
- Senior Manager R&D Global Program Leadership Date: Nov 13, 2025 Location: Weston, United States, Florida, 33325 Company: Teva Pharmaceuticals Job Id: 64961 **Who ... affect program delivery or quality. Work with all key departments-clinical, commercial, regulatory , CMC , operations, IP, TPO-to ensure program quality and… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this....method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors...of combined experience in pharmaceutical/medical device industry as a manager in Manufacturing, QA or QC role supporting GMP… more
- ThermoFisher Scientific (Wilmington, NC)
- …people and communities depend on - now and in the future. **Role:** CTM, Senior **Location:** US-Remote, East Coast HIGHLY preferred, may look at Central, but will ... complexity, and may assume regional lead or Clinical Study Manager responsibilities. **Key Responsibilities** : + Manages all clinical...members involved in the study set up (DM, Reg, CMC etc ): ensure feasibility report are exhaustive, Review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- AbbVie (Barceloneta, PR)
- …with experience in drug substance and/or drug product transfers. The program manager is to provide strategic oversight for one or more industrialization programs, ... use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable program… more
- Pfizer (Groton, CT)
- …scope, the position provides growth opportunities in Operations, Strategy, and Digital. ** Senior Manager :** + Formal leadership role of data coordinators ... ** Regulatory , Data Steward & Team Lead (Sr. Manager )** Vault RIM process and system is highly dependent...for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO… more
- Takeda Pharmaceuticals (Lexington, MA)
- …the biologics portfolio and provide technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... data, and drive data-based decisions and solutions. + Experience contributing to regulatory filings for biologics (eg, CMC sections, control strategy… more
- Boehringer Ingelheim (Duluth, GA)
- …or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project ... Operations Excellence Partner is to partner with the USA Regulatory Affairs team in executing key strategic and operational...initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
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