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New Jersey - Vice President, Global Regulatory Strategy
Refer job# EO2423870
Vice President, Global Regulatory Strategy
The candidate will, under the general direction of the SVP Worldwide Safety and Regulatory (WSR), be responsible for providing leadership and support for all Consumer Healthcare regulatory activities worldwide. Will define innovative regulatory strategies for global new products and claims and be responsible for ensuring the integrity and timeliness of all global Regulatory submissions. Will also be responsible for all interactions with regional and local regulatory agencies. Lead global, regional and local regulatory affairs departments focused on effective commercial, development and manufacturing support and efficiencies. Develop and implement innovative Regulatory strategies for global, regional and local growth opportunities (e.g. new products and claims). Lead all company contacts with Global, Regional and Local Regulatory agencies and Board's of Health. Provide leadership, strategic and tactical Regulatory support for all Rx-OTC Switch programs. Provide guidance and interpretation of current and future regulations and regulatory legislation. Identify opportunities for exclusivity and differentiation for all new products and claims. Collaborate with all Consumer R&D functions in the development of new products and claims and the maintenance of existing products and claims. Collaborate with Global, Regional and Local Marketing in the development of new products and claims opportunities. Engage in all competitive claims challenges. Oversee the Advertising and Labeling Review processes. Collaborate within WSR to coordinate overlapping activities and present one voice to regulatory agencies. Lead and develop staff.

The candidate should have M.D. or Ph.D./PharmD in biological or chemical sciences OR a J.D. degree with strong scientific background. Must have 15 years of industry experience with 10+ years of experience in regulatory affairs. Should have significant industry experience in consumer healthcare (OTC's, Dietary Supplements). Must have proven record of addressing regulatory challenges linked to successful new product and claims strategies. Rx to OTC switch experience is required. Expert knowledge of global and local regulations and regulatory requirements is preferred. Understanding of OTC environment and complexity of products (i.e., drugs, dietary supplements, devices and cosmetics) is desired. Familiarity and positive relationships with major regulatory bodies (e.g., FDA, EMEA, etc.) is preferred.

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