- Cardinal Health (Trenton, NJ)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions ... 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
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… 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,...or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug… more
- Ascendis Pharma (Princeton, NJ)
- …with prescription drug , biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs,… more
- 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
- Sanofi Group (Morristown, NJ)
- …and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge,...FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications. + Primary Liaison… more
- Bristol Myers Squibb (Princeton, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... strategic advice for the development of Office Of Prescription Drug Promotion advisory submissions and sub part e submissions...compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with… more
- Edgewell Personal Care (Allendale, NJ)
- …+ Sound knowledge of the consumer products industry. + Experience with OTC drug regulations for FDA , Health Canada, and TGA. Medical devices's regulations ... the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing,… more
- Sumitomo Pharma (Trenton, NJ)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more