- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- Bristol Myers Squibb (Princeton, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with sub part e and 2253 regulations + Lead… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …**Preferred Qualifications:** + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other ... global regulatory agencies and experience negotiating with regulatory authority personnel (eg FDA , Notified Bodies) preferred + Must demonstrate ability to… more
- Organon & Co. (Jersey City, NJ)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...with the FDA , EMA, or other EU regulatory agencies, including telephone calls and e-mail; chair meetings… more
- Sumitomo Pharma (Trenton, NJ)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …compliance with US pharmacovigilance regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits ... clinical and medical standpoint, identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100%… more
- Merck (Rahway, NJ)
- …quality and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, ... + Experience leading or supporting direct interactions with major Health Authorities (eg, FDA , EMA). + Demonstrated success in managing regulatory filings across… more
- Sanofi Group (Morristown, NJ)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... furthers the company's strategic goals while effectively managing legal and regulatory risks and upholding the company's integrity and reputation. Additionally, the… more
- Cardinal Health (Trenton, NJ)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- System One (Princeton, NJ)
- …experiments, analyze data, draw conclusions, and recommend actions + Basic knowledge of FDA regulatory requirements for OTC products + Ability to prioritize and ... policies for working in the laboratory designated for the development of FDA regulated products + Assist in maintaining laboratory compliance including equipment… more