- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …* Determine "best practices" to seamless Research to Development transitions of nominated drug candidates to Regulatory Toxicology and R&D Drug Development ... for internal (Research, Development, Medicine, Regulatory ) and external regulatory interactions involving investigative toxicology de-risking of drug … 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
- Pfizer (New York, NY)
- …device development or relevant experience in the pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs ... **JOB SUMMARY** Global Regulatory Sciences (GRS) serves as strategic leader and... leader who has global mindset and expertise of drug development and product lifecycle processes in support of… 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
- Fairview Health Services (Minneapolis, MN)
- …will provide all pharmaceutical care within their assigned areas including clinical services, drug distribution, regulatory compliance (TJC, CMS, etc.), drug ... education, medication safety, quality assurance, customer service, process improvement and regulatory compliance. This position may also participate in education of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet ... analysis and reporting of Gilead clinical data in efficiently achieving regulatory , scientific and business objectives. The Director will be primarily responsible… 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