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Senior Director, Regulatory Affairs - Advertising & Promotion

Company: DBV Technologies
Location: Summit
Posted on: November 11, 2019

Job Description:

DBV has an exciting opportunity to lead the development and implementation of Advertising and Promotion review process for the launch of the company's first product and to serve as the US Regulatory Strategy Lead for a Phase II/III candidate.

As the Senior Director, Regulatory Affairs, you will provide regulatory leadership and guidance to the marketing teams during the development, review and approval of product labeling and advertising material; and oversight of the advertising/promotional activities from concept through submission to the FDA, while serving as the FDA liaison.
Additional responsibilities will include collaborating with the VP, RA and the global regulatory affairs team to define and execute US regulatory strategies ensuring product development and approvals are consistent with corporate objectives and applicable regulations and guidelines. You will support planning and execution of major US submissions and responses to regulatory authorities related to INDs, amendments, aggregate reports, BLAs and supplements within company timelines and in accordance with regulations and guidelines.
Interacting and managing internal/external functional stakeholders effectively to gather data and develop documentation required for on-time submissions will be essential. By ensuring submission documents are accurate, compliant, and high-quality, this will allow for smooth and rapid approvals from regulatory authorities. You will develop and maintain relationships with FDA review staff; assist with the management/conduct of regulatory interactions with FDA, assuring that interactions are focused, amicable and documented. And, you will monitor the regulatory landscape for competitive products and apply this knowledge to the development of DBV products.
Qualifications:

  • BS in biochemistry, chemistry, biology or related pharmaceutical fields required; advanced degree (PhD, PharmD, MS) strongly preferred
  • 10+ years pharma (or combination of Pharma, Biotech or Medical Device) experience and 5+ years Regulatory Affairs experience involving the direct implementation of promotional labeling and advertising regulations required
  • Experience providing regulatory input and evaluation as part of a promotional review committee required
  • Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities is essential

Keywords: DBV Technologies, New York , Senior Director, Regulatory Affairs - Advertising & Promotion, Executive , Summit, New York

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