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Vice President of Regulatory Affairs

Vice President of Regulatory Affairs

We represent an outstanding opportunity for a regulatory affairs executive to oversee and support the regulatory affairs department within a highly regarded pharmaceutical company with headquarters in Research Triangle Park, North Carolina, as Vice President of Regulatory Affairs (Vice President).  This role reports directly to the Executive Director of Product Development and is part of the management team.

The Vice President will provide regulatory advice and strategy to management, and regulatory guidance and support to development teams within the organization.  He/she will also coordinate submissions and FDA interaction for assigned US projects, as well as serve as liaison between license partners and business development, on behalf of product development. 

Qualifications

The ideal candidate will be a strong manager with excellent communication and organization skills.  A solid understanding of, and experience with, FDA regulations and guidelines, as well as considerable exposure to the regulatory review process, is essential.

A demonstrable track record of leadership and the ability to interpret complex clinical data for agency submission and/or publication are needed.  Experience with bringing products to the European market and knowledge of EU regulations and guidelines is also required.  A PhD is preferred for this role.

The Organization

The organization is a publicly traded pharmaceutical company based in Research Triangle Park, North Carolina.  The company is highly regarded in the industry for its drug delivery technology, pipeline, and strong commercial alliances.