- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport...MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- AbbVie (North Chicago, IL)
- …such as analytical, process engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs , supply chain and Operations ... manner, independently or under the direction of a more senior scientific leader. This position will be an integral...+ Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Gilead Sciences, Inc. (Foster City, CA)
- …summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead ... an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The...summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed… more
- Capgemini (New York, NY)
- …& Experience** **Skills & Experience (Required)** + **12+ years** in regulatory affairs ; direct leadership of **IND/NDA/BLA/MAA** submissions (10+ successful ... Capgemini Invent - LS Reg Affairs & Qlty - Sr Consultant...by technology created with purpose. **Your Role** As a Senior Consultant, you'll act as a **trusted regulatory… more
- Gilead Sciences, Inc. (Washington, DC)
- …health authorities and cross-industry associations. + Matrix/coordinate/lead strategy development with CMC Regulatory Affairs Policy Advisory and ... for Quality Policy issues in conjunction with the Gilead CMC Regulatory Policy Office. The role will...on North American facing assets. + Develop, advise global senior leadership, and implement solutions to address regulatory… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructively challenge...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… more
- Parexel (Nashville, TN)
- … regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary ... to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Sumitomo Pharma (Lincoln, NE)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
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