- Insmed Incorporated (NJ)
- …both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and ... will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Merck & Co. (Rahway, NJ)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... strategic and tactical input from diverse disciplines (eg, Medical Affairs , Outcomes Research, Market Access, Biostatistics and Research Decision Sciences,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment… more
- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …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 ... team.** **Primary Responsibilities:** **This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry,… 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
- 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
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO ... and other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development to post-authorization… 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 ... Senior RA Specialist will also support related regulatory affairs activities, such as development, execution...requirements and support the proposed product claims. + Review CMC changes and determine regulatory reporting category… 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
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Kelly Services (South San Francisco, CA)
- …& Clinical** is seeking a Vice President/ Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late clinical-stage, ... in a high-growth environment-trust **The Experts at Hiring Experts.** **Title:** Vice President/ Senior Vice President, Global Regulatory Affairs **Pay:**… 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. + Participate in...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… 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
- Bristol Myers Squibb (Princeton, NJ)
- …projects. + Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them. ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command of US… more
