- 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
- BeOne Medicines (Emeryville, CA)
- …with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General Description:** The Director, Regulatory Affairs will be responsible for developing, implementing,...both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Oversee the planning, authorship, review, and delivery of all major clinical regulatory submissions, including: + New Drug Application (NDA) + IND/CTA filings ... Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a… more
- BeOne Medicines (San Mateo, CA)
- …with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite ... **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory … more
- Parexel (Providence, RI)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... FDA, EMA, and Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small… 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