Every day, we rise to the challenge to make a difference and here's how the Head of US Regulatory Affairs Advertising and Promotion role will make an impact:
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 while providing strategic regulatory leadership to enable compliant business growth and innovation and acting as the primary subject matter expert on U.S. promotional regulations.
Key responsibilities for this role include:
- 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.
The minimum qualifications for this role are:
- Minimum of a bachelor's degree (or equivalent) and relevant industry experience required. A degree in scientific discipline is strongly preferred. An advanced degree (MS, PharmD, MD) in a scientific discipline is a plus, A minimum of 10 years of experience in Regulatory Affairs with at least 5 years subject matter expertise as strategic leader in Ad Promo. Related experience and/or education may be considered.
- Must possess 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.
- Must possess excellent analytical, written and verbal communication, interpersonal, and project management skills.
- Must possess a strong work ethic and have outstanding organization and time management skills. Must have strong computer skills and be proficient within the Microsoft Office Suite.
- This 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.
- Proficiency in speaking, comprehending, reading, and writing English is required.
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.
