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Job #02941

About our client Our client is a rapidly growing development-stage pharmaceutical company that is focused on the commercialization of therapeutics for patients with unmet needs that are suffering from chronic kidney disease. With offices in Canada and the US the company boasts a world class management team with unparalleled expertise in this area, a varied selection of cutting edge protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Director of Regulatory Affairs Chicago, Illinois 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) Assist with the technical transition from pre-approval research to post-approval commercial phase 9) Ensure compliance with all agency-regulated late-stage development and post-approval activities including timely and accurate submissions of annual reports as well as supplemental filings 10) Build and maintain good business and working relationships with internal as well as external groups 11) Ensure that company personnel are trained appropriately 12) Communicate regulatory status and risks (related to products and compliance) to senior management 13) Ensure that all regulatory and quality-related activities and functions are current, implemented fully and compliant with defined standards 14) Work with internal departments as well as external CROs and CMOs to ensure timely and cGXP-compliant disposition of products 15) Interface directly with regulatory agencies to host regulatory inspections compliance activities by communicating openly and effectively 16) Work to develop a team-based approach as well as to lead and motivate regulatory 17) Provide guidance on system-validation tasks and product release 18) Assist senior management to formulate as well as establish company policies and operating procedures (SOPs) 19) Participate in activities related to potential in-licensing and out-licensing of products Requirements 1) B. Sc. in Biological or Chemical Sciences (advanced degree preferred) 2) 5 – 10 years of pharmaceutical industry regulatory experience (regulatory submissions to support product approvals and renewals, post-marketing strategies and commercial awareness) 3) Minimum 2 years of people and project-management experience 4) Knowledge of quality management systems a plus 5) Excellent presentation skills 6) Superb interpersonal and communication (verbal) skills 7) Ability to work independently, both as a functional leader and a participant in teams 8) Willingness to travel – up to 20% (within the US and internationally)