- Regeneron Pharmaceuticals (Warren, NJ)
- …practice, compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance with FDA , EMEA, ICH and GCP guidelines as ... well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals… 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 Promotion ... promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable. + Provides US RA AdPromo strategic guidance and… more
- Edgewell Personal Care (Allendale, NJ)
- …Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, interpreting, ... the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the design...efficiencies. + Represent EPC before government authorities such as FDA , Health Canada, TGA and others. + Maintains understanding… more
- Sumitomo Pharma (Trenton, NJ)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of...with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on … more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …standpoint, identify and respond to signal analysis, and submit to regulatory agency ( FDA /Health Canada) within timelines to achieve 100% compliance with US ... regulatory norm + Anchor drug safety regulatory inspection in US ( FDA regulatory agencies),participate in audits and provide support in external audits.… more
- Envista Holdings Corporation (Mahwah, NJ)
- …execution of manufacturing processes for individualized dental products regulated by the FDA that are produced through a Computer Automated Manufacturing Cell or ... documents that will be reviewed and audited by the FDA . + Assist the Quality team as the process...in Site Acceptance Tests for new manufacturing processes, ensuring compliance with quality standards. + Conduct pre-study analysis to… more
- Fujifilm (Trenton, NJ)
- …on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide ... to HLUS and its subsidiary companies on substantive legal topics, including FDA marketing and advertising regulations and other regulations specific to Life… more
- Sanofi Group (Morristown, NJ)
- …counsel concerning a broad range of legal issues, including, interpretation of FDA and other regulations, including the False Claims Act, Anti-Kickback Statute and ... legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA /regulatory issues and fraud and abuse) as well as proposed solutions… more
- Bayer (NJ)
- …and accurate implementation of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations ... and analyzes and evaluates requests for new or revised labeling initiated by FDA or Bayer HealthCare Pharmaceuticals and manages action required to implement; +… more
- Merck (Rahway, NJ)
- …expertise in the design, development, and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, ... FDA regulations). Actively seek out, anticipate, and solve significant...external suppliers and partners to ensure the quality and compliance of components used in Autoinjectors, driving performance, accountability,… more