Exec Dir Regulatory Affairs in Westlake Village, California at Arcutis Biotherapeutics Inc

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.

Roles & Responsibilities

1. 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.
2. Shape promotional strategy by advising cross-functional teams on permissible claims, appropriate use of evidence, benefit-risk communication, and regulatory risk mitigation.
3. Review materials, and oversee/provide guidance on review of materials, and lead PRC meetings.
4. Provide regulatory guidance to Medical team as needed and review pertinent Medical materials.
5. 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.
6. Own PRC process and drive successful implementation. Engage in continuous improvement to maximize efficiency and ensure success. Oversee PRC planning and workload assessment.
7. Manage complex negotiations with internal and external stakeholders.
8. 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.
9. Facilitate submission of branded promotional materials to FDA on Form 2253.
10. Act as main point of contact with FDA’s Office of Prescription Drug Promotion (OPDP).

Job Complexity, Discretion and Interaction

The Executive Director has a direct impact on promotional compliance risk, marketing execution timelines, and company reputation with regulators and external stakeholders. This position ensures PRC decisions are consistent, defensible, and aligned with corporate risk standards. The position interacts internally with all levels of staff, including members of the company’s leadership and executive teams and interacts with external people and organizations, including OPDP at FDA. The position enables efficient, predictable execution through process discipline and upstream regulatory engagement.

Supervision

This position leads and manages the activities of staff and contractors within the Regulatory Affairs Advertising and Promotion group.

Education & Licenses and Experience Education & Licenses and Experience

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. An advanced degree (MS, PharmD) is preferred.

Competencies & Skills

• 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
• Dermatology experience preferred and/or proven ability to work across therapeutic areas
• 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

Why Join Us?

Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!

This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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.

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