Head of US Regulatory Affairs Advertising and Promotion

Viatris•Washington, DC

1d•Hybrid

About The Position

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, Viatris provides access at scale, supplying high-quality medicines to approximately 1 billion patients around the world annually. The Head of US Regulatory Advertising & Promotion (A&P) is a senior leadership role responsible for ensuring that all U.S. advertising, promotion, and related communications for company products comply with federal regulations, company policies, and industry standards. This role provides strategic regulatory leadership to enable compliant business growth and innovation and acts as the primary subject matter expert on U.S. promotional regulations.

Requirements

Minimum of a bachelor’s degree (or equivalent) and relevant industry experience
A minimum of 10 years of experience in Regulatory Affairs with at least 5 years subject matter expertise 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
Strong cross-functional collaboration and stakeholder management skills
Expertise in promotional review processes (e.g., PSMR – Promotional Submission Management Review)
Ability to lead regulatory committees and influence business strategy
Experience with medical, scientific, and promotional materials compliance
Strong communication and presentation skills for internal and external audiences
Excellent analytical, written and verbal communication, interpersonal, and project management skills
Strong work ethic and outstanding organization and time management skills
Strong computer skills and proficiency within the Microsoft Office Suite
Proficiency in speaking, comprehending, reading, and writing English

Nice To Haves

A degree in scientific discipline is strongly preferred
An advanced degree (MS, PharmD, MD) in a scientific discipline is a plus

Responsibilities

Develop and implement A&P regulatory strategies
Establish and maintain local policies, SOPs, and compliance frameworks aligned with global practices ensuring consistent, risk-based decision-making across all promotional activities
Partner with medical affairs, legal, marketing, and commercial teams to ensure promotional materials (e.g., physician/patient sales, marketing, educational materials, press releases) are accurate, balanced, substantiated and aligned with overall brand strategy and business objectives
Serve as the primary contact with the FDA’s Office of Prescription Drug Promotion (OPDP) within the U.S. Food and Drug Administration
Lead submissions, risk mitigation strategies, and regulatory interactions including advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions
Review and approve promotional materials for completeness, accuracy, and consistency with approved labeling
Assess clinical evidence supporting claims
Build a best-in-class A&P local function with efficient, compliant review and execution processes including optimization of MLR/PRC review workflows and continuous process improvement initiatives
Management of a 4–5-member team including coaching, performance management, and capability development
Monitor FDA, FTC, and SEC enforcement trends and communicate risks to senior leadership, translating external insights into proactive guidance and risk mitigation strategies for the business
Maintain relationship with Global Head of Labeling, Advertising & Promotion to ensure consistency across regions