IpsenDirector, Regulatory Affairs
Jun. 2012 - Apr. 2013Director, Regulatory Affairs, Endocrinology: Demonstrated exceptional leadership of endocrinology therapeutic area, including portfolio of therapeutic products for treatment of growth disorders, endocrine tumors, and related gastrointestinal indications for U.S. and Canada. Supervise Regulatory Associate and Regulatory Contractor, perform role of key liaison to FDA, ensure compliance with regulatory reporting requirements, and lead FDA interactions, submissions, and meetings. Apply strategic and submission expertise to regional project teams and submission teams for NDA projects. Provide critical analysis and input into Regulatory Strategic Assessments for U.S. requirements. Ensure adequacy of regulatory strategies to address U.S. FDA requirements while providing alignment with EU strategy when possible. • Presented strategic insight and submission planning for 2 supplemental new drug applications in area of endocrine tumors at international project team meetings at EU headquarters.
• Alleviated potential shortage of drug for treatment of growth disorders through provision of effective regulatory strategy and filing of multiple submissions. • Oversaw completion of key submission for new syringe needle protection system.