- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC , Clinical, Quality) to facilitate ... the future of science, we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory team to help us expand what's… more
- Merck & Co. (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
- AbbVie (North Chicago, IL)
- …. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Sumitomo Pharma (Lincoln, NE)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- 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
- 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
