Head of US Regulatory Affairs Advertising and Promotion

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 we provide access at scale currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of lifes moments from birth to the end of life acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day we rise to the challenge to make a difference and heres 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 withmedical affairs legal marketing and commercial teamsto 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 FDAs 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 abest-in-class A&P local functionwith efficient compliant review and execution processes including optimization of MLR/PRC review workflows and continuous process improvement initiatives.

• Management of a 45-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 bachelors 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 ofFDA promotional regulations guidance and enforcement trends.

• Strongcross-functional collaborationand stakeholder management skills.

• Expertise inpromotional review processes(e.g. PSMR Promotional Submission Management Review).

• Ability tolead regulatory committeesand influence business strategy.

• Experience withmedical scientific and promotional materialscompliance.

• 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 $151000 - $314000.

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.