- Regeneron Pharmaceuticals (Troy, NY)
- …with the Health Authority. **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global regulatory strategies ... strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the ... (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director ... Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Boehringer Ingelheim (Athens, GA)
- …marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical ... + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, 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. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Gilead Sciences, Inc. (Washington, DC)
- …degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas ... with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies,… more
- ThermoFisher Scientific (Greenville, NC)
- …biopharmaceutical company, all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a ... RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners...partners closely with Clinical Operations, Clinical Development, Safety, and CMC leadership and serves as a key point of… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Lilly (Indianapolis, IN)
- …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
- 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 At Capgemini...(no sponsorship). **Preferred** + Former **FDA/CDER/CBER** reviewer experience. + VP/ Director Regulatory experience in **first-time submissions** (IND… more
- Lundbeck (Deerfield, IL)
- …Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead ... Director US Regulatory Global Strategic Labelling...Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements ( CMC… more
- J&J Family of Companies (Spring House, PA)
- …application. We invite candidates from any location to apply. The Director , Global Regulatory Leader in Global Regulatory Affairs will be responsible for ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** ...& Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is… 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
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …precision mental health care. 2. Provides consultation to investigators on all regulatory oversite of the research portfolio and in particular clinical trials. ... and family psychotherapy. 5. Provides consultation to professional staff within CMC VAMC system and to community providers, concerning clinical assessment findings… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's ... advocating sound for policies + Provides internal stakeholders (eg, Global Government Affairs , R&D, Commercial, Legal) with a strategic regulatory policy… more
- Bristol Myers Squibb (Madison, NJ)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… 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 CNS...Analytics, Early Commercial, Medical Affairs , Nonclinical Toxicology, Clinical Pharmacology, CMC , and… more
- Organon & Co. (Plymouth Meeting, PA)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- University of Colorado (Aurora, CO)
- …field or equivalent. + Certified as a Clinical Research Professional (CCRP) + Regulatory Affairs Certification (RAC) for drugs and devices + Prior experience ... **IND/IDE Office Assistant Director ** **Description** **University** **of Colorado Anschutz Medical Campus** **Department: Clinical Research Operations and… more
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