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Director/Senior Director, Regulatory Affairs Advertising & Promotion

Reference Number: 4207
Location: MA

Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Director/Senior Director, Regulatory Affairs Advertising & Promotion.

Major tasks and responsibilities will include:

  • Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards (PRB) for the successful launch of the company’s commercial programs.
  • Serves as the primary regulatory advertising and promotion reviewer on cross-functional Medical Review Boards (MRB) for the compliant scientific exchange of information of investigational programs.
  • Acts as the primary contact with the FDA Office of Prescription Drug Promotion (OPDP), which includes providing response to agency inquiries and managing company requests for advisory review.
  • Leverages scientific and regulatory knowledge to support business objectives and initiatives in order to develop solutions to complex US promotional issues.
  • Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
  • Collaborates with Regulatory counterparts in order to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
  • Contributes to the training of personnel on advertising and promotional materials, as required.
  • Oversees relevant external vendors and consultants, particularly as it relates to ex-US advertising and promotional activities.
  • Monitors US regulatory promotional environment and keeps the organization up-to-date on the issuance of new FDA regulations/guidance, relevant FDA enforcement action, general awareness of industry practices, etc.

We seek candidates with the following qualifications:

  • Bachelor’s degree required. Advanced degree highly preferred (MS, PhD, PharmD, or JD).
  • Must have a minimum of 10 years of pharmaceutical industry experience, including at least 7 years of experience focused on the regulatory review of advertising and promotion materials for prescription drug products.
  • Requires experience launching new products and/or new indications.
  • Experience in oncology and/or rare diseases highly preferred.
  • Direct experience interacting with OPDP required.
  • Experience working on an accelerated approval product, as well as experience with ex-US promotional activities highly preferred.
  • Must be able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate.
  • Requires solid understanding of business goals and common marketing concepts/tools, including the internet and social media.
  • Experience in managing multiple global programs required.

 If interested, please email your resume as a Word attachment to us, reference 4207.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.