- 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
- 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
- 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
- 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
- University of Southern California (Los Angeles, CA)
- …the expertise in professional practice, education or research in the areas of drug and device development and regulatory considerations. Specific areas of ... students within the masters and doctoral programs of the Department of Regulatory and Quality Sciences (http:// regulatory .usc.edu). These positions seek to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Virology drug development, working collaboratively for the development plans, regulatory interactions, and commercial evaluation of a Gilead Virology compound in ... Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …agency (FDA/Health Canada) within timelines to achieve 100% compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection ... the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review current reporting period against historical data to… more
- J&J Family of Companies (Titusville, NJ)
- …of medical publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug /device regulatory strategies ... reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project physicians. Team… more