Vice President, Advertising and Promotion, Regulatory Affairs

Key result areas (major duties, accountabilities and responsibilities)

• Leads regulatory review and approval for promotional, medical education and corporate materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies and best practices.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues.
• Ensures global regulatory compliance while effectively managing business risks.
• Maintains awareness of competitive activities by monitoring major US medical congresses in assigned therapeutic area.
• Marksers US regulatory promotional environment by reviewing and interpreting regulatory promotional guidance documents, untitled and warning letters, and by attendance of major FDLI, DIA and other industry/FDA meetings to inform internal standards.
• Presents to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Serves as the company's primary liaison with FDA’s APLB, including advisory comments, voluntary submissions and responses to inquiries for respective product(s) and ensures materials are submitted to FDA via 2253.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• Supports input to metrics to measure and track the effectiveness and efficiency of the promotional review process and provides recommendations for process improvements to address potential issues.
• Operates independently, with recognition of when to consult senior leadership to identify and escalate risks.

  Qualifications & Skills

  • Advanced degree (PharmD, PhD, MS, JD) preferred.
  • Minimum of 12+ years’ experience in Regulatory Affairs promotion and advertising working with prescription drug or biologic products.
  • Deep expertise in FDA Ad/Promo landscape.
  • Solution oriented and demonstrated skilled negotiator with internal stakeholders and FDA.
  • Experience in a rare disease is essential and gene therapy is strongly preferred.
  • Proven experience serving as the independent regulatory reviewer for promotional materials within a biotechnology or pharmaceutical company.
  • Experience in leading activities for APLB submissions, including time of first use sub-missions, requests for advisory comments, and 30-day submissions for Subpart H products.
  • Demonstrated knowledge and understanding of US regulations for drug promotion/advertising and US labeling.
  • Demonstrated skill in evaluating potential regulatory risk within promotional materials and effectively communicating those risks in a clear, actionable manner to MLR stakeholders and cross-functional partners.
  • Demonstrated leadership skills in highly matrixed environments.
  • Ability to manage and bring working teams together for common objectives.
  • Understanding of business goals of the business franchise, marketing concepts and tools.
  • Proven ability to analyze and interpret efficacy and safety data.
  • Excellent oral and written skills and project timeline management skills.
  • Prior experience with launch readiness planning and execution.
  • Prior experience with Veeva PromoMats and RIM.
  • Flexible, entrepreneurial by nature, a collaborative team member.
  • Proven track record of overseeing regulatory requirements outside US FDA (e.g. EMA, MHRA, Health Canada, PMDA).