Director, Regulatory Affairs, Advertising & Promotion

Role Summary

Director, Regulatory Affairs Advertising and Promotion will report to the Vice President Global Regulatory Affairs. This position will be responsible for providing commercial regulatory strategy to enable the US business to meet its commercial needs in a compliant matter. The role will be an internal expert on the US FDA regulations, guidelines and trends governing the promotion of prescription products including gene therapies.

Responsibilities

• Serves as the primary regulatory reviewer to approve promotional, payor, corporate materials to assess for regulatory compliance with the applicable regulations, guidance documents, and internal policies and best practices.
• Function as the “R” in the core Medical, Legal, and Regulatory (MLR) review process.
• Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
• As part of the MLR process support diffusing team disputes and serving as a dependable negotiator.
• Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by APLB, and by attendance of major FDLI, DIA and other industry/FDA meetings.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Serve as the company's regulatory liaison to the FDA’s APLB for respective product(s) and ensure materials are submitted to FDA via 2253.
• Liaison with APLB regarding advertising and promotion for assigned products, including products approved under Subpart H. Establishes strong and positive working relationship with APLB reviewers. Manages APLB queries on assigned products.
• Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
• Support input to metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
• Operates independently, with recognition of when to consult senior leadership to identify and escalate risks.

Qualifications

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, JD) preferred.
• Minimum of 8 years’ experience in drugs or biologics in Regulatory Affairs.
• Minimum of 5 years’ experience in Regulatory Affairs promotion and advertising working with prescription drug or biologic products.
• Experience in a rare disease company preferred.
• Experience in gene therapies is 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.
• In-depth 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. Ability to manage and bring working teams together for common objectives.
• Understanding of business goals of the involved business franchise, marketing concepts and tools.
• Proven ability to analyze and interpret efficacy and safety data.
• Excellent oral and written skills, timeline responsibilities.
• 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).