Sr. Director, Lead Regulatory Ad/Promo

• Manages and provides regulatory oversight to a team of direct reports responsible for regulatory reviews and strategic advice relating to promotional activities and medical, nonpromotional materials for assigned brands/franchises.

• Guides, coaches, and develops direct reports on personal growth opportunities, organizational impact, and professional development.

• Partners with commercial and medical functions on cross-functional committees, task forces, and other forums to provide strategic regulatory advice aligned with business goals and objectives, FDA regulations/guidances, PhRMA guidelines, and company policy.

• Applies regulatory and industry knowledge to business initiatives, developing solutions to navigate complex U.S. regulatory standards for promotional and select medical activities.

• Ensures regulatory compliance while effectively identifying, assessing, and managing business risks.

• Maintains awareness of competitive activities by monitoring major U.S. medical meetings where assigned therapeutic area products are promoted.

• Collaborates with cross-functional colleagues to provide regulatory input on study designs and U.S. labeling, including assessment of the feasibility of promoting potential data and claims.

• Participates in U.S. labeling negotiations and FDA meetings, as appropriate, to support regulatory strategy and business objectives.

• Serves as the regulatory advertising and promotion reviewer and/or regulatory representative on medical teams for assigned disease areas, products, launch indications, and other complex or high-priority programs.

• Models and promotes effective AI use across the team by embedding AI tools into workflows, guiding responsible AI practices, and fostering a culture of experimentation, innovation, and continuous learning.

Essential Requirements

• BS Degree or equivalent required.

• Minimum 7 years of regulatory experience, including in-depth knowledge of U.S. regulations governing drug promotion/advertising and U.S. labeling.

• Experience leading activities for OPDP submissions, including time of first use submissions, requests for advisory comments, and 30-day submissions for Subpart H products.

• Experience supporting regulatory activities associated with product and/or indication launches.

• Proven ability to analyze and interpret efficacy and safety data and apply insights to regulatory decision-making.

• Strong understanding of business goals, marketing concepts, and tools, with the ability to work independently using sound negotiation and decision-making skills.

• Demonstrated interpersonal, communication, analytical, and problem-solving skills, with the ability to work effectively in a multi-disciplinary environment.

Desirable Requirements

• Advanced degree preferred (MS, PhD, PharmD, or JD).

• Experience leading a team of regulatory professionals and managing/directly developing people preferred.