- Sanofi Group (Morristown, NJ)
- …data submissions. + Recognized authority in business process optimization in regulatory affairs . + Expert understanding of capability-based planning, agile ... capability roadmaps with enterprise impact, serve as a strategic bridge between regulatory SMEs, business process owners, and digital product teams, and lead the… more
- J&J Family of Companies (Titusville, NJ)
- …for product hierarchies, nomenclature, and lifecycle transitions. + Partner with Regulatory Affairs , Clinical Operations, Supply Chain, and Commercial to ... & Supply (PTDS), and connecting seamlessly with clinical trial and regulatory data. This lifecycle mastering ensures continuity into commercial brand naming… more
- South Jersey Industries (Atlantic City, NJ)
- … agencies, other departments and external customers in the support of regulatory affairs and pricing objectives. Essential Duties and Responsibilities: + ... Oversee and prepare regulatory filings and associated tariffs including the supporting work...models to analyze the impact of changes in law, regulatory rules or policies, offering of new rate schedules,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs , Global Clinical Development (late phase), Data & ... endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory , and commercial functions. As an industry-leading expert and… more
- Astrix Technology (Monmouth County, NJ)
- …quality standards. + Collaborate with cross-functional teams including drug safety, regulatory affairs , clinical development, and biostatistics. + Interpret and ... experience in medical writing with a focus on pharmacovigilance or regulatory affairs . + Strong knowledge of drug safety regulations and pharmacovigilance… more
- Novo Nordisk (Plainsboro, NJ)
- …Qualifications + Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs , etc.); advanced degree preferred + 7+ years of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... scientists in the project in collaboration with the Safety Officer, Regulatory Strategist, Statistics and other key functional representatives to deliver development… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC, Biostatistics, GCO, in the execution of ... Lead, Clinical Scientist. and other functional areas such as GCO, biostats, regulatory , pharmacovigilance. The Director will be a key contributor to INDs, NDAs,… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... study protocols are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans. The Clinical… more
- System One (Park Ridge, NJ)
- …+ Partner with product development, packaging, operations, quality, and regulatory affairs to integrate microbiological and sterilization requirements ... technical direction, leading high-impact sterilization programs, and ensuring full regulatory compliance across the product lifecycle-from development through commercialization.… more