Head of U.S. Regulatory Advertising & Promotion and Strategic Commercialization

Roles And Responsibilities

Provide senior regulatory expertise in FDA advertising and promotion requirements, including OPDP guidance, enforcement trends, and industry best practices.

Lead regulatory oversight and approval for promotional and medical education materials (HCP, consumer, digital, omnichannel, speaker programs, and congress materials).

Drive a future focus through a digitally enabled, AI-forward regulatory capability, including evolving content creation, modular content, and review processes.

Serve as primary regulatory interface with FDA OPDP, including advisory comments, voluntary submissions, and responses to inquiries.

Interpret enforcement actions (Untitled Letters, Warning Letters) to inform internal standards.

Partner cross-functionally to enable compliant product differentiation and value communication.

Provide regulatory input into launch readiness, messaging frameworks, and lifecycle strategies.

Lead and scale U.S. Ad/Promo capabilities to support multiple launches across therapeutic areas.

Future-proof the MRC/MMRC process to align with automation, artificial intelligence, and modern go-to-market models.

Balance compliance and commercial objectives through risk-based decision making.

Contribute to shaping long-term Vision and growth strategy across multiple assets and indications.

Leadership & Governance

Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.

Establish governance frameworks and decision-making processes for promotional review.

Drive consistency in regulatory interpretation across brands and therapeutic areas.

Provide training and guidance to internal stakeholders.

Education, Qualifications And Experience

• 15+ years of regulatory experience with 5–7+ years in Ad/Promo roles.
• Deep expertise in FDA Ad/Promo landscape.
• Proven leadership in matrixed environments and experience supporting product launches.
• Strong strategic mindset and executive communication skills.
• Digitally savvy leader comfortable operating in AI-enabled environments.
• Ability to innovate and evolve regulatory processes.