- 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
- 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
- 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
- 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
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health Authorities. +… more
- Bausch + Lomb (Springfield, IL)
- …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
- ThermoFisher Scientific (Wilmington, NC)
- …ensure audit readiness. -Advanced understanding of global/regional/national requirements and regulatory affairs procedures for clinical trial authorization, ... ICH and other global regulatory guidelines, with in-depth expertise in regulatory specialty areas such as preclinical, clinical, CMC , MDD, publishing, etc.… 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
- 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
- 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
- Pfizer (Groton, CT)
- …: + Bachelor's and 6+ years of experience or Master's degree in Life Sciences, Regulatory Affairs , Data Management, or related field. + 5+ years of experience in ... for initial registrations. They work in close collaboration with Regulatory Strategy, CMC Leads, Clinical, Non-Clinical, RIO... Regulatory Affairs or Regulatory Operations… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... **Job Summary** The Senior Director will serve as the Translational Medicine...Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC , and… 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 (Lexington, MA)
- …colleagues from Research, Quality Control, Process Development, Drug Product Development, and Regulatory Affairs to drive alignment on potency strategy and ... of regulatory guidance and industry standards relevant to analytical CMC activities, particularly in the development and validation of potency assays +… more