Head of US Regulatory Affairs Advertising and Promotion

## About the role

Mylan Pharmaceuticals Inc. (Viatris) is hiring a senior leader to be the Head of US Regulatory Advertising & Promotion (A&P). In this role you will ensure that all U.S. advertising, promotion, and related communications for company products comply with federal regulations, company policies, and industry standards while providing strategic regulatory leadership to enable compliant business growth and innovation. You will act as the primary subject matter expert on U.S. promotional regulations and be the primary contact with the FDA’s Office of Prescription Drug Promotion (OPDP).

The position follows a hybrid work model, with an expectation of being onsite at the DC office three days per week. Occasional travel may be required based on business needs.

### What you will do day to day

You will develop and implement A&P regulatory strategies and establish and maintain local policies, SOPs, and compliance frameworks aligned with global practices. You will partner closely with medical affairs, legal, marketing, and commercial teams to ensure promotional materials — for physician and patient audiences, sales and marketing, educational materials, and press releases — are accurate, balanced, substantiated and aligned with overall brand strategy and business objectives.

You will lead interactions with the FDA OPDP including submissions, risk mitigation strategies, advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions. Your review and approval of promotional materials will assess completeness, accuracy, and consistency with approved labeling and clinical evidence supporting claims.

Building a best-in-class local A&P function is part of the role: you will optimize MLR/PRC review workflows, drive continuous process improvements, and manage a 4–5-member team with coaching, performance management, and capability development.

You will monitor FDA, FTC, and SEC enforcement trends and communicate potential risks to senior leadership, translating external insights into proactive guidance and risk mitigation strategies. You will also maintain a relationship with the Global Head of Labeling, Advertising & Promotion to ensure consistency across regions.

### Skills, experience and education we require

- Minimum of a bachelor’s degree (or equivalent) and relevant industry experience required. A degree in a scientific discipline is strongly preferred. An advanced degree (MS, Pharm. D, MD) in a scientific discipline is a plus. Related experience and/or education may be considered.

- A minimum of 10 years of experience in Regulatory Affairs with at least 5 years subject matter expertise as a strategic leader in Ad Promo.

- Must possess expert knowledge of regulatory guidance pertaining to advertising and promotion for pharmaceutical products, and deep knowledge of FDA promotional regulations, guidance, and enforcement trends.

- Strong knowledge of the regulatory environment and FDA processes; experience with promotional review processes (e.g., PSMR — Promotional Submission Management Review).

- Ability to lead regulatory committees and influence business strategy, and experience with medical, scientific, and promotional materials compliance.

- Strong cross-functional collaboration and stakeholder management skills, excellent analytical, written and verbal communication, interpersonal, and project management skills.

- Must have strong computer skills and be proficient within the Microsoft Office Suite.

- Proficiency in speaking, comprehending, reading, and writing English is required.

### Compensation and employer information

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $151,000 - $314,000. At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.