- Sanofi Group (Morristown, NJ)
- …The Director plays an active role in shaping labeling strategy early in product development by providing regulatory input into clinical development ... race is on to speed up drug discovery and development to find answers for patients and their families....(eg, CCDS, USPI, SmPC) for assigned products throughout the product lifecycle. + Provide regulatory labeling leadership to cross-functional… more
- Organon & Co. (Jersey City, NJ)
- …in-markets, regulatory history, historical performance (production and compliance), new product or market launches, historical relationship between Organon and the ... + Provide support to the contract manufacturer to facilitate and validate new product introductions and/or transfers. + Assist with and/or lead the development ,… more
- Integra LifeSciences (Princeton, NJ)
- …microbiological design outputs, review and assess the accuracy and sustainability of product requirements as they pertain to sterility assurance and microbiology and ... of medical device quality systems, and a commitment to ensuring product safety and compliance. The ideal candidate should demonstrate proficient experience… more
- Sanofi Group (Morristown, NJ)
- …of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for lifecycle ... or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update… more
- J&J Family of Companies (Titusville, NJ)
- …we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working to make that future a reality for ... Excellence Neuroscience, Schizophrenia Team and will coordinate our learning and development efforts for the sales team. Primarily, the Senior Learning Manager… more
- J&J Family of Companies (Raritan, NJ)
- …Cardiovascular is responsible for leading the clinical-commercial optimization strategy of product development and life cycle management strategies and plans ... Medical s/he will partner closely with the GMA Operations Leader, Regional Medical TA/ product leaders and Clinical Development Leader to develop an integrated… more
- Integra LifeSciences (Princeton, NJ)
- …and interpretation for industry related regulations within the framework of organizational product and sustaining development processes. + Utilize coaching and ... and will have the experience to proactively identify and lead business development opportunities or address issues outside of their core responsibilities with… more
- Merck (Trenton, NJ)
- …for Dermatology in key countries and regions. They are impactful members of Product Development Team sub-teams and Global Human Health commercialization teams. ... colleagues from key countries and regions. + Serves as an impactful member of Product Development Team sub-teams (eg, Clinical, V & I, Commercial, Publications).… more
- Bristol Myers Squibb (Princeton, NJ)
- …and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process. + Understanding of policy, laws, ... working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co- development , in-licensing, and… more
- Merck (Rahway, NJ)
- …and external GxP laboratories + Represent the potency group on cross-functional product development teams and effectively communicate with stakeholders in ... minimum of 14 years of relevant experience in the pharmaceutical industry. + Expertise in applying advanced cell biology...of potency data in context of broader process and product development . + Working knowledge of regulatory… more