- Merck & Co. (Durham, NC)
- …Sustainability portfolio in its entirety involving any of the following: Regulatory compliance with internal interpretations Manage project strategy for the Durham ... systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment. PROBLEM… more
- Merck & Co. (Rahway, NJ)
- …and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires ... and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and… more
- Formation Bio (New York, NY)
- …of technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or engineering to ... other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory , clinical pharmacology and project management to support short and long… more
- Insmed Incorporated (NJ)
- …a strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams ... and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and commercial objectives.… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, ... supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of ... AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a… more
- Merck & Co. (Durham, NC)
- …systems regarding functionally of equipment and relied on as SME during regulatory discussions for Utilities and the commissioning of that equipment. PROBLEM ... and predictive maintenance programs to assure compliance with quality, regulatory , and reliability requirements and goals.Track maintenance and reliability metrics… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, ... supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We… more
- Insmed Incorporated (NJ)
- …for creating and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties ... This position will also work with staff to provide in-depth regulatory expertise, robust interpretation, clear guidance and employee education regarding a… more
- ValSource, Inc. (Rahway, NJ)
- …client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves extensive travel to various ... activities, and ensuring compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams… more
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