- Lilly (Philadelphia, PA)
- …life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific … more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. **Job ... Gilead and help create possible, together. **Job Description** **Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:**… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager, CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage biotechnology ... authorities worldwide. You will assist in the development and execution of CMC regulatory strategies, regulatory submissions (IND, BLA, NDA) in the area of… more
- Regeneron Pharmaceuticals (Troy, NY)
- …goals, and current policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT products ... industry experience including a minimum of 5 years of relevant CMC Regulatory experience including experience in the field of cell and gene… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Participate in cross-functional meetings for program-specific discussions, proactively identify CMC regulatory issues and suggest appropriate strategies to ... Support CMC development activities from a regulatory standpoint during early phase, development, submissions and post market requirements for gene therapies. **A… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** **Intern - CMC Regulatory Affairs - Biologics** **Foster City, CA** As a Gilead ... subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with … more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory ... Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical… more
- Merck (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead development… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Actalent (Boston, MA)
- …to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Bristol Myers Squibb (Summit, NJ)
- …team with projects to support department goals and objectives. **Key Responsibilities** + Support Regulatory CMC Cell Therapy group in the preparation of CMC ... interactions with Global Health Authorities. + Attend and participate in various Reg CMC and matrix team meetings as needed and applicable + Manage and prioritize… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Strategic Projects requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard projects with ... the development of our new chemical entities and provide regulatory advice regarding global CMC regulatory requirements to achieve development objectives. +… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... strategy + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- AbbVie (North Chicago, IL)
- …works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and ... teams to negotiate, influence, and provide strategic advice. Responsibilities: + Prepares CMC regulatory product strategies. Prepares and manages regulatory … more
- Amgen (Washington, DC)
- …of processes and tools to support effective and efficiency compilation of post-approval CMC regulatory activities. This internship will provide the incumbent the ... opportunity to understand responsibilities of a CMC regulatory scientist. The specific goals of the internship are: + Collect regulatory intelligence for… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Senior Manager, Regulatory CMC Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... immunological diseases. Position Summary: Vera is seeking a Senior Manager, Regulatory CMC to join an experienced, fast-paced and collaborative team. The Senior… more
- BeiGene (San Mateo, CA)
- …aggressive timelines. The individual will provide support to cross-functional teams on regulatory CMC strategies. **Essential Functions of the job:** + Develop ... and implement small molecule regulatory CMC strategies as well as author CTD CMC sections for assigned projects to ensure on-time and high-quality global… more
- Gilead Sciences, Inc. (Foster City, CA)
- …teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager. Participates in ... Qualifications** + Master's Degree with 3+ years of industry experience in CMC regulatory affairs; or Bachelor's Degree with 5+ years of pharmaceutical CMC… more
- Takeda Pharmaceuticals (Boston, MA)
- …or Engineering Discipline, higher degree preferred + 10+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a ... be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy for US + Able… more
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