- Danaher Corporation (Deer Park, IL)
- …and alignment across global and culturally diverse stakeholders. + Experience with drug development and drug regulatory procedures. Leica Biosystems, ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process. Travel, Motor… more
- Merck (De Soto, KS)
- …N/A **Required Skills:** Adaptability, Audits Compliance, Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global ... **SUMMARY OF POSITION** This position is responsible for ensuring regulatory filings of animal health products in pursuance of...with applicable USDA regulations and is within the Global Regulatory Affairs Bio team. This position is based in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the federal Anti-Kickback ... of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Organon & Co. (Jersey City, NJ)
- …developmental compounds or marketed products throughout the entire life cycle of the drug . + Represent Global Regulatory Affairs within our company's internal ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director,...meetings with FDA or EMA at any phase of drug development. Lead cross-functional efforts to prepare and lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including ... submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Takeda Pharmaceuticals (Boston, MA)
- … experience in the pharmaceutical/biotech industry. + Experience in global drug development regulations, regulatory submissions, lifecycle management, compliance ... immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is accountable for overseeing… more
- Lilly (Indianapolis, IN)
- …(Federal Register, media reports, etc.) **Additional Skills/Preferences:** + Knowledge of drug development process, regulatory /business strategies and plans + ... Sr. Director, GRA, Product Communications, is responsible for demonstrating regulatory leadership and influence in facilitating effective partnerships with assigned… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Utlizes profound GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and overcome challenges ... Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and… more
- Merck (Rahway, NJ)
- …BS in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. + MS with 10+ years ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world.… more