- IQVIA (Durham, NC)
- …Management (Associate) Director will play a critical role in supporting the Regulatory Affairs and Drug Development Solutions (RADDS) team-not through direct ... alignment to help drive success. This is role focuses on the Drug Development & Regulatory Strategy (DDRS) offerings within RADDS. The individual will be focused… more
- Danaher Corporation (Boston, MA)
- …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
- UPMC (Pittsburgh, PA)
- …Drug Administration (FDA) is essential. **OR** 1+ years' experience in drug development, regulatory or clinical operations functions is preferred, Exceptional ... cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time ** Regulatory Specialist** to help support the Oncology Clinical Research Services team… more
- Guidehouse (Silver Spring, MD)
- …and ability to network and build consensus within a multi-disciplinary organization. + Drug regulatory experience is desired, particularly in regulatory ... Do** **:** + To provide scientific and technical guidance to Applied Regulatory Science management leadership, scientists and project teams. + Help interpret… more
- Bayer (Cambridge, MA)
- …for clinical trials and CDx/IVD for marketing applications) that are aligned with drug development; + Coordinate regulatory consultancy input into IVD/CDx ... regulatory submissions for IVD/CDx, including for use in drug clinical trials; + Ability to knowledgeably discuss and...or related sciences preferred with 10+ years in biomarker/IVD/ regulatory affairs / drug -related development / medical… 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 (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
- ProMedica Health System (Toledo, OH)
- …Medication Safety Committee, coordinating RCAs, and implementing strategies to reduce adverse drug events (ADEs). * Regulatory Compliance: Ensures adherence to ... RELATIONSHIPS/SUPERVISORY RESPONSIBILITIES The Director of Medication Safety, Quality, and Regulatory Compliance will supervise system-wide initiatives for medication safety,… more
- University of Colorado (Aurora, CO)
- …**Condition of Employment:** **Preferred Qualifications:** + Experience with investigational drug services, clinical research operations, or IRB/ regulatory ... of pharmacy practice** with a particular interest in clinical research, investigational drug management, and regulatory compliance in academic or healthcare… more
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