- 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 ... + Represent our company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies, including telephone calls… more
- Ascendis Pharma (Princeton, NJ)
- …medical, payor, corporate, and other non-promotional materials to assess for regulatory compliance with the applicable regulations, guidance documents, and ... appropriate pre-approval and/or disease education communications + Serve as the company's regulatory liaison to the FDA 's Advertising and Promotional Labeling… more
- Edgewell Personal Care (Allendale, NJ)
- …within the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP....efficiencies. + Represent EPC before government authorities such as FDA , Health Canada, TGA and others. + Maintains understanding… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... our teams accelerate progress. This individual will be responsible for providing regulatory review and approval of US promotional and other product and… 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, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Merck (Trenton, NJ)
- …and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and ... Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical … more
- System One (Florham Park, NJ)
- …Overview: This role will support in the preparation and submission of electronic regulatory documents through the FDA and Health Canada Electronic Submission ... in accordance with established timelines and submission dates in compliance with local and global regulatory requirements...CMC, DMF, and labeling/SPL submission documents. + Familiar with regulatory guidelines, such as FDA , EMA, MHRA,… more
- Integra LifeSciences (Princeton, NJ)
- …uploads and verification, and ensuring high-quality, timely support for the Global Regulatory Affairs function and broader organizational compliance at Integra ... gap assessments, gathers impact data, and prepares comprehensive reports to inform regulatory strategy and compliance . + Understand and execute the requirements… more
- Kelly Services (Bridgewater, NJ)
- …to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and FTC activity (as ... advertising to keep abreast of market promotional and advertising strategies. + Provide regulatory support as needed for FDA warning and untitled letters, FTC… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …on submissions and other issues. + Independently reviews product changes to ensure regulatory compliance , including assessment of impact to US and CE Mark ... documentation and product labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions, EU technical files, and other… more