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

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement the U.S. regulatory strategy for promotional materials throughout the product lifecycle.

• Act as the main regulatory authority for compliance with FDA advertising and promotion standards.

• Oversee and approve promotional and medical education materials from a regulatory standpoint.

• Propel a future-oriented approach through a digitally enabled, AI-enhanced regulatory capability.

• Analyze enforcement actions to shape internal standards.

• Collaborate across functions to facilitate compliant product differentiation and effective value communication.

• Provide regulatory insights for launch readiness, messaging strategies, and lifecycle planning.

• Lead and enhance U.S. Ad/Promo capabilities to support numerous launches across various therapeutic areas.

• Modernize the MRC/MMRC process to ensure alignment with automation.

⛳️ Requirements

• Over 15 years of regulatory experience, including 5–7+ years in Ad/Promo positions.

• Extensive knowledge of the FDA Ad/Promo landscape.

• Demonstrated leadership in matrixed environments with experience in supporting product launches.

• Strong strategic thinking and executive communication abilities.

• A digitally adept leader who is comfortable operating within AI-enabled settings.

• Capability to innovate and advance regulatory processes.

🏝️ Benefits

• Retirement savings plans.

• Health benefits and additional perks in accordance with the terms of the relevant plans and program guidelines.