- System One (Florham Park, NJ)
- …sciences, pharmacy, bioscience; advanced degree preferred. + 7+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a ... Job Title: AD - Dir Regulatory Affairs Strategy Location: Florham Park, NJ (50%...IND applications and 1 NDA) + Knowledge of and Compliance with FDA, EMEA, PMDA guidances + Performance will… more
- Sanofi Group (Morristown, NJ)
- …documents (such as IB, PBRER, DSUR, RMP, etc.). + Support operational and compliance activities for assigned regulatory deliverables and develop regulatory ... **Job Title:** Regulatory Strategist- Innovation Franchise **Location:** Cambridge, MA, Morristown,...related field with at least 5 years of relevant pharmaceutical /biotechnology industry experience, including at least 3 years of… more
- Sanofi Group (Morristown, NJ)
- …documents (such as IB, PBRER, DSUR, RMP, etc). + Supports operational and compliance activities for assigned regulatory deliverables and develops regulatory ... **Job Title:** Regulatory Strategist - Vaccines **Location** : Swiftwater, PA/...field) preferred. + At least 6 years or prior pharmaceutical /biotechnology industry experience, including at least 3 years of… more
- Integra LifeSciences (Princeton, NJ)
- …projects from the business to meet quality standards, timelines, company goals, regulatory compliance , and cost management/process efficiency goals. The Sr. ... ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be managing the strategic and tactical labeling… more
- Bausch + Lomb (Trenton, NJ)
- …global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance . + Provide… more
- System One (Park Ridge, NJ)
- …+ Reviews scientific documents for accuracy, formatting, consistency, and compliance with scientific principles, regulatory guidelines, company standards, ... Title: Sr Regulatory Writer - R&D Location: Park Ridge, NJ...software + Good working knowledge of scientific terminology, medical, pharmaceutical , and research concepts. + Working knowledge of analytical… more
- Merck (Rahway, NJ)
- …Affairs (GRA) Product Managers (PMs) are responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical ... for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products. The Co-op will… more
- Sumitomo Pharma (Trenton, NJ)
- …+ Minimum 2 - 3 years of relevant experience in biotech or pharmaceutical industry specific to Pharmacovigilance operations and compliance . + Strong ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …materials or other types of product communications to provide comprehensive regulatory compliance guidance. + Ensures product promotional materials are ... (life sciences disciplines strongly preferred) + 4+ years of experience in promotional compliance and product labeling in the pharmaceutical industry + Advanced… more
- Nestle (Bridgewater, NJ)
- …Operating Procedures) and WIs (Work Instructions) and documentation standards. + Ensure regulatory compliance is aligned with industry best practices and ... and processes supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance , quality management and compliance ,… more
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