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Job #03105

About our client Our client is a dynamic and growing, independent contract drug development and consulting company. Employees at this company are experienced and highly qualified team players, essential to its success. Position Location Director of Regulatory Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Contribute (proactively) to formulating global regulatory strategies that interpret and reflect regulatory as well as corporate guidelines 2) Plan, manage and implement regulatory programs in multidisciplinary project teams for all products (late-stage development through to commercialization) 3) Represent the company at FDA, DDMAC and other regulatory agencies 4) Initiate and respond to regulatory agency contacts (e.g. telephone, email, meetings, etc.) to negotiate successfully with regulatory agencies and achieve business objectives 5) Manage and account for regulatory reviewing of promotional materials as well as to ensure regulatory compliance of product brand 6) Review global product promotional materials and press releases 7) Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality 8) Work with internal departments as well as external CROs and CMOs to ensure timely and cGXP-compliant disposition of products 9) Interface directly with regulatory agencies to host regulatory inspections compliance activities by communicating openly and effectively 10) Work to develop a team-based approach as well as to lead and motivate regulatory 11) Provide guidance on system-validation tasks and product release 12) Manage clinical projects in overseas locations 13) Assist senior management to formulate as well as establish company policies and operating procedures (SOPs) 14) Participate in activities related to potential in-licensing and out-licensing of products requirements Requirements 1) Bachelor’s degree in a scientific field 2) 5 years’ experience in pharmaceutical solid-forms and liquids 3) Background in Chemistry, Pharmacy or any related field 4) Experience in supporting business development efforts, specifically in offshore locations like India 5) Experience in production or sales 6) Knowledge of GMP