Head of US Regulatory Affairs - Advertising & Promotion

1w1 week ago

Viatris

Washington, US · Full-time · $151,000 – $314,000

About this role

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands. It empowers people worldwide to live healthier, supplying high-quality medicines to 1 billion patients annually across life's moments. The Head of US Regulatory Affairs Advertising & Promotion ensures compliant advertising and promotion for company products.

This senior leadership role provides strategic regulatory leadership as the primary subject matter expert on U.S. promotional regulations. It develops A&P regulatory strategies and maintains policies, SOPs, and compliance frameworks aligned with global practices. Responsibilities include partnering with medical, legal, marketing, and commercial teams for accurate promotional materials.

Day-to-day involves serving as primary contact with FDA’s Office of Prescription Drug Promotion, leading submissions and responses to enforcement actions. Review and approve promotional materials for accuracy and alignment with labeling. Monitor FDA, FTC, and SEC enforcement trends to communicate risks to senior leadership.

Build a best-in-class A&P function with optimized MLR/PRC review workflows and process improvements. Manage a 4-5 member team through coaching and performance management. Maintain relationships with Global Head of Labeling, Advertising & Promotion for regional consistency.

Requirements

Bachelor’s degree (or equivalent) required; degree in scientific discipline strongly preferred
Advanced degree (MS, PharmD, MD) in scientific discipline a plus
Minimum 10 years experience in Regulatory Affairs with at least 5 years as strategic leader in Ad Promo
Expert knowledge of regulatory guidance pertaining to advertising and promotion for pharmaceutical products
Strong knowledge of regulatory environment and FDA
Deep knowledge of FDA promotional regulations, guidance, and enforcement trends

Responsibilities

Develop and implement A&P regulatory strategies; establish and maintain local policies, SOPs, and compliance frameworks aligned with global practices
Partner with medical affairs, legal, marketing, and commercial teams to ensure promotional materials are accurate, balanced, and substantiated
Serve as primary contact with FDA’s Office of Prescription Drug Promotion; lead submissions, risk mitigation, and regulatory interactions
Review and approve promotional materials for completeness, accuracy, consistency with labeling, and supporting clinical evidence
Build best-in-class A&P local function with efficient review processes and continuous improvement initiatives
Manage 4–5 member team including coaching, performance management, and capability development
Monitor FDA, FTC, and SEC enforcement trends and communicate risks to senior leadership
Maintain relationship with Global Head of Labeling, Advertising & Promotion for consistency across regions