- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies and ... team. The candidate will be responsible for the development and execution of global regulatory strategies for the assigned drug/device portfolio. This role… more
- Lilly (Indianapolis, IN)
- …guidance to team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on ... are determined to make life better for people around the world. **The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …quality principles, and regulatory expectations to support relevant global regulatory submissions. + Authors, reviews and edits CMC sections and provides ... functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC...considerations via risk-based approaches. + Continually monitors the evolving global regulatory landscape regarding CMC … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Takeda Pharmaceuticals (Boston, MA)
- …with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor for alignment on project ... risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product /… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late ... **The Experts at Hiring Experts.** **Title:** Vice President/Senior Vice President, Global Regulatory Affairs **Pay:** $300,000-$400,000 per year,… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sumitomo Pharma (Lincoln, NE)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more