Director, Regulatory Affairs, Advertising and Promotion

Your Role

At the intersection of science, strategy, and compliance, this role offers a rare opportunity to shape how life-changing therapies are brought to patients through compliant, compelling promotion.

The Director, Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable for the review, approval, and strategic oversight of promotional materials.

• Ensures compliance with applicable laws, regulations, and FDA guidance while providing independent, expert regulatory counsel to cross-functional stakeholders.
• Operates with a high degree of autonomy, enabling the development of compliant and effective promotional strategies that support business objectives and drive organizational success.
• Ledges and represents Regulatory Affairs on Promotional Review Committees, ensuring that U.S. promotional materials for prescription products meet regulatory requirements and align with company strategy.
• Manages correspondence, addresses complex regulatory inquiries, and oversees submissions for advisory comment.
• Proposes innovative and compliant regulatory strategies and solutions to complex promotional concepts, balancing business objectives with regulatory risk.
• Leads the strategic evaluation and regulatory positioning of proposed product claims for assets in development, including oversight of Important Safety Information (ISI) and Brief Summary documents, as appropriate.
• Drives the development, implementation, and continuous improvement of advertising and promotion processes, standards, and standard operating procedures to enhance operational efficiency and ensure sustained regulatory compliance.
• Assesses evolving regulatory trends, guidance, and enforcement activities, proactively advising Regulatory Affairs teams, review committees, and cross-functional stakeholders to inform business decisions and ensure compliance.
• Partners with Quality on internal audits and CAPAs, providing regulatory leadership to ensure alignment with compliance requirements and to drive continuous improvement.
• Provides coaching and informal mentorship to team members, including onboarding support for new hires, fostering a culture of consistency, capability development, and regulatory excellence.

Minimum Qualifications

• Bachelor’s degree in a science or health-related discipline; advanced degree (PhD, MD, MS, or PharmD) strongly preferred.
• Minimum 8+ years of pharmaceutical industry or related experience, with a minimum of 5 years as a primary reviewer of advertising and promotional materials.
• In-depth knowledge of FDA regulations governing the development, review, and approval of prescription drug promotional materials, including OPDP and APLB processes.
• Demonstrated ability to identify and deliver solutions to complex promotional regulatory challenges, balancing business objectives with regulatory risk.
• Strong diplomacy, interpersonal, and negotiation skills, with a track record as a consensus builder across cross-functional teams.

Preferred Qualifications

• Experience leading or supporting drug promotion activities and product launches within a pharmaceutical or biopharmaceutical environment.
• Comprehensive understanding of the Regulatory Affairs landscape for prescription drugs, including labeling strategy and clinical development alignment.
• Demonstrated ability to lead enterprise-wide training initiatives and foster a culture of continuous improvement and regulatory compliance.
• Excellent verbal and written communication skills, with the ability to translate complex regulatory concepts for diverse audiences.