- 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
- Sanofi Group (Cambridge, MA)
- …and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post-marketing stages. The ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse… more
- Ascendis Pharma (Princeton, NJ)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs, ... MBA, JD) preferred. + Minimum of 8 years' experience in drug , biologic and/or combination products in Regulatory Affairs or related field. + Minimum of 5 years… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as evolving regulatory trends and developments for their impact on drug and device development activities and on existing development strategies. + Lead requests ... policy context for business decisions. + Provide strategic regulatory advice to RA colleagues on drug ...strategic regulatory advice to RA colleagues on drug development and device projects, registration, and marketed products… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Outlook, Word, PowerPoint, and Excel. + Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy ... **Description** The Regulatory Affairs Fellow - Advertising and Promotion is...build a foundational understanding of compliance with the Food Drug and Cosmetic Act (FDCA), FDA Guidance, and the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as evolving regulatory trends and developments for their impact on drug development activities and on existing development strategies. + Share new/novel "on the ... Outlook, Word, PowerPoint, and Excel. + Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy… more
- The Clorox Company (Alpharetta, GA)
- …a robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring ... OTC drug regulations/monographs. + Proven ability to lead project regulatory strategies and influence cross-functional teams. + Excellent written and verbal… more