ASSOCIATE DIRECTOR REGULATORY AFFAIRS

This position requires a seasoned, Senior Regulatory Professional. The incumbent will need extensive (10-15 years) experience, a high level of skill and a track record of substantial accomplishment in Regulatory Affairs especially in new Drug Approvals including OTC Switch Applications. Ability to exercise sound judgement and independent action is essential. The incumbent will be called on to develop Regulatory, strategies, and action plans and will direct all aspects of Regulatory Programs to effectively and efficiently bring new product opportunities to market. The position also has responsibility to ensure that marketed products are in compliance with applicable Government Regulations.

 

Examples of major activities necessary to fulfill the positions basic purpose follow:Act as a primary Regulatory Advisor to project specific business teams and ensure sound, timely, Regulatory counsel, guidance and services on a proactive basis to assigned business clients on existing and new OTC products. Develop Regulatory strategies and provide leadership to business clients in development of new products plans. Ensure expeditious development of Regulatory submissions (e.g. IND, NDA, ANDA) for new Rx to OTC switch products and other new OTC products/indications to gain earliest feasible approvals for new products. Act as official company representative to conduct liaison with FDA to secure approvals of NDA's for new products.Recruit, train, and develop direct reports, ensuring ability to lead all Regulatory initiatives.Maintain a culture that fosters team work with marketing, legal and other scientific personnel to develop, support and execute sound Regulatory strategies.

 

Examples of the education, skills, experience and personal characteristics necessary for success in the assignment include the following:

 

QUALIFICATIONS:Advanced Degree(s) (Ph.D., JD) preferred.Minimum 10 years-preferably 15+ years Regulatory experience in IND/NDA submissions including OTC switch and FDA Advisory Committee reviews.10+ years in leadership/supervisory role. Ability to make sound, well-reasoned, high quality decisions.Entrepreneurial energy and enthusiasm to drive for results.Skill and determination to reach successful win/win outcomes in negotiations with both inside team clients and outside parties e.g., Regulatory agencies.Ability to successfully influence others and contribute in a positive way to business team decision making.

 

Katie Corliss

Director, Life Sciences Practice

ESG, Inc.

Ph: 207-646-9200 x122

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