Sr. Director, Lead Regulatory AdPromo

• 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.