Executive Director - Regulatory Affairs, Advertising & Promotion

Arcutis Biotherapeutics • US,

13h

About The Position

The Executive Director - Regulatory Affairs, Advertising & Promotion is accountable for the strategic and operational leadership of the company’s advertising and promotion regulatory function and the end-to-end Commercial Promotional Review Committee (PRC) process. The position leads a team of regulatory professionals responsible for the review of materials in accordance with applicable regulations, guidance documents, and internal policies/SOPs and for providing the content and oversight for 2253 submissions to FDA. The Executive Director collaborates with Commercial colleagues, providing proactive regulatory input into materials under development, reviews (and oversees review of) submitted materials and leads PRC meetings. This position manages escalations, as necessary, and other relevant communications to senior leadership within the company. This role collaborates with stakeholders in continuous improvement efforts related to the overall PRC process.

Requirements

• Deep knowledge of US promotional regulations and standards
• Demonstrated successful leadership of PRC or related cross-functional review team
• Proven ability to build and optimize operational processes using performance metrics and continuous improvement methods
• Experience supporting product launches
• Strong executive presence with ability to influence, negotiate, and drive alignment across Commercial, Medical, Legal, Compliance, and agencies
• Experience in the review of all types of marketing media, including the use of digital and social media in pharmaceutical promotion
• Collaborative in nature, able to work within a cross-functional team to ensure compliance while meeting the needs of the commercial and medical organizations
• Experience in people leadership and coaching
• Excellent verbal and written communication skills
• Typically requires a Bachelor’s degree in a scientific discipline and at least 12 years of related experience, or the equivalent combination of education and experience.

Nice To Haves

• An advanced degree (MS, PharmD) is preferred.
• Dermatology experience preferred and/or proven ability to work across therapeutic areas

Responsibilities

• Understand and evaluate all perspectives (Commercial, Legal/Compliance, Medical) and provide expert regulatory guidance for promotional, disease state education, corporate and other non-promotional materials for relevant products and associated therapeutic areas to cross-functional teams.
• Shape promotional strategy by advising cross-functional teams on permissible claims, appropriate use of evidence, benefit-risk communication, and regulatory risk mitigation.
• Review materials, and oversee/provide guidance on review of materials, and lead PRC meetings.
• Provide regulatory guidance to Medical team as needed and review pertinent Medical materials.
• Review and interpret enforcement actions, keeping current with industry changes relating to advertising and promotion, interpret new FDA Guidance to Industry documents, and, as applicable, evaluate related internal policies/best practices and processes. Communicate to cross-functional team as appropriate.
• Own PRC process and drive successful implementation. Engage in continuous improvement to maximize efficiency and ensure success. Oversee PRC planning and workload assessment.
• Manage complex negotiations with internal and external stakeholders.
• Continue to build and lead high performing team of Regulatory Advertising and Promotion professionals. Establish training, coaching, and peer review practices to ensure uniform interpretation of standards and consistent review outcomes.
• Facilitate submission of branded promotional materials to FDA on Form 2253.
• Act as main point of contact with FDA’s Office of Prescription Drug Promotion (OPDP).

Benefits

• Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive