- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- ThermoFisher Scientific (Greenville, NC)
- …a matrixed environment. + Acts as a labeling strategist within Global Regulatory Affairs (GRA), ensuring alignment of company position, labeling requirements, ... insight. + Act as key partner to GRA Regions, Regulatory CMC , and Supply Chain to ensure...as a labeling **strategist and thought leader** within Global Regulatory Affairs . + Strong understanding of **… more
- Merck (North Wales, PA)
- **Job Description** The Associate Director, Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team. The ... application of regulatory science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements to the world by… more
- Lilly (Indianapolis, IN)
- … colleagues in GRA, GOLD, and GRA- CMC and when necessary, within regulatory bodies worldwide. The Associate will utilize regulatory knowledge, CT ... recent years. The role of the Clinical Trial Label Regulatory Compliance Associate is to participate in...related scientific discipline) + 3 years industry-related experience in regulatory affairs , CT Labeling and/or drug development… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... ** Associate Director, Small Molecule Analytical Development** + Lead...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country ...Regulatory Health Authorities, and others. As GRA Device Associate in the GRA Device Digital and Diagnostic team… more
- Merck (Rahway, NJ)
- …Managers in Value & Implementation (which is this job), Development, and CMC ; Discovery Portfolio Managers; Alliance Managers; Project Management Office (PMO); and ... Administrative Professionals. **Position Description/Summary:** The GPAM Associate Director, Value & Implementation Project Manager (VIPM), is a core member of Value… more
- Merck (West Point, PA)
- …on project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs , clinical operations, and CMC teams. + ... on clinical implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert within multidisciplinary project… more
- AbbVie (Barceloneta, PR)
- …to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for managing… more
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