Executive Director, Regulatory Affairs, Advertising and Promotion

The Executive Director, Regulatory Affairs, Advertising and Promotion ensures regulatory compliance of BI’s promotional communications while enabling business objectives. The role provides strategic leadership across promotional review governance, shapes internal policy through participation in the Human Pharmaceuticals Review Committee, and strengthens regulatory intelligence through cross‑functional and external partnerships. The Executive Director oversees and develops a team of regulatory professionals specializing in Rx drug advertising and promotion, representing the function within the Regulatory Affairs leadership team and supporting global discussions, training, and alignment on U.S. FDA promotional requirements.

• Leads, develops, evaluates, and retains high‑performing regulatory professionals who support the regulatory review of Rx drug advertising and promotion.
• Determines regulatory risk strategies for BI drug and biologic promotion.
• Participates in HPRC meetings and strategic discussions related to risk assessment for promotional materials.
• Assesses regulatory risk by applying enforcement history, regulatory guidance, market trends, and other intelligence sources.
• Participates in multi‑functional teams that develop internal policies and procedures related to Rx drug promotion.
• Identifies and addresses process or procedural gaps that impact efficiency and quality in advertising and promotional labeling.
• Mentors Regulatory Affairs Ad/Promo team members, supports development planning, and provides meaningful assignments that promote growth.
• Represents U.S. Ad/Promo regulatory interests in discussions with global colleagues on promotional tactics.
• Ensures global promotional tactics intended for U.S. markets comply with FDCA requirements and FDA expectations.
• Serves as the Regulatory Affairs representative in Line Management Escalation meetings for promotional materials.
• Participates in senior management escalation meetings, ensuring decisions balance regulatory guardrails with business needs.
• Applies deep knowledge of FDCA, 21 CFR regulations, and FDA promotional guidance to evaluate promotional claims.
• Balances regulatory requirements with business needs to support compliant promotional communication.

• Bachelor’s degree in life sciences or a legal field; advanced degree preferred.
• Candidates with non‑science degrees may qualify with relevant professional experience.
• Minimum 8–10 years of pharmaceutical industry experience, including substantial Regulatory Affairs experience.
• Strong knowledge of Rx drug development, the FDCA, and 21 CFR regulations related to drug promotion.
• Ability to self‑direct workload, reprioritize effectively, and meet deadlines.
• Ability to analyze and interpret scientific data and regulatory guidelines to apply appropriate risk‑assessment principles.
• Demonstrated competence in conflict resolution and ability to work toward consensus in cross‑functional settings.
• Previous direct managerial experience with demonstrated leadership capabilities preferred.
• Strong written and verbal communication skills, including comfort with public speaking, presentations, and training delivery.

 

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.