- Teva Pharmaceuticals (West Chester, PA)
- …role that will be responsible for developing, coordinating, and implementing regulatory strategies for drug development programs for innovative biologic ... Director, Regulatory Affairs Date: Dec 2, 2025 Location: West... knowledge of and submission experience with investigational new drug applications (INDs) and new drug applications… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Taiho Oncology (Princeton, NJ)
- …prepares and directs global regulatory affairs activities and provides regulatory guidance during drug development, approval and post approval processes ... Proposition: Join our dynamic and expanding mid-size company as a Sr. Manager, Regulatory Affairs Strategy. In this role, you will support submissions for various… more
- ThermoFisher Scientific (Washington, DC)
- …and integrated development plans, delivering on Thermo Fisher's Accelerator (TM) Drug Development solutions. + Defining essential regulatory achievements and ... on - now and in the future. **About the role:** The **Sr Director, Regulatory Strategy** will be responsible for advising clients on strategic regulatory … more
- Astellas Pharma (Northbrook, IL)
- …scope. + Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug ... **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United...Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will… more
- Parexel (Des Moines, IA)
- …Adobe Acrobat, TVT, PromoMats, GLAMS. Competencies: * Deep understanding of regulatory requirements for drug development, global labeling, and post-marketing. ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- ThermoFisher Scientific (Wilmington, NC)
- …intelligence within the biopharmaceutical industry. + Strong understanding of global regulatory frameworks and drug development lifecycle. + Excellent ... depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is...Remote, East Coast is highly preferred **Position Summary** The Regulatory Intelligence Manager will play a pivotal role in… more
- Abbott (Alameda, CA)
- … regulatory requirements. + Complies with applicable US Food and Drug Administration (FDA) and international regulatory requirements, Company policies, ... working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site at our… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …group is dedicated to developing innovative datasets and modeling approaches to support drug development and regulatory evaluation. We focus on two major ... patient demographics, and clinical trial data. 2. Modeling for Regulatory Science - Leveraging drug development and regulatory datasets to build models… more
- BeOne Medicines (Emeryville, CA)
- …driving strategies, programs, and external engagement + Understanding of the prescription drug regulatory environment and clinical trial submission process in ... representative patient enrollment. This role collaborates across Clinical Operations, Regulatory , Development, and corporate functions to embed diversity into study… more