Dir Regulatory Affairs Ad & Promo

Arcutis Biotherapeutics Inc; Westlake Village (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Arcutis Biotherapeutics Inc is seeking a Director, Regulatory Affairs Advertising & Promotion to lead regulatory review for promotional, disease-state and non-promotional materials, ensuring compliance with FDA guidance and internal policies.

The role interfaces with Commercial, Legal/Compliance and Medical teams to develop compliant ad promo strategies, review materials in Veeva Vault, and mentor junior team members while providing coverage during peak periods.

Qualifications

• Bachelor’s degree in a scientific field and 8–10 years of related experience or equivalent.
• 3-5 bullet points for regulatory experience in promotional materials.
• 4+ years reviewing ads with cross-functional teams and leadership.

Responsibilities

• Provide regulatory review for promotional, disease-state, and non-promotional materials

Skills

Regulatory strategy

Promotional review

Cross-functional collaboration

Veeva Vault usage

Education

Bachelor’s degree in scientific discipline

Tools

Veeva Vault PromoMats

Job description

The Director, Regulatory Affairs Advertising & Promotion is responsible for providing the regulatory review on the Promotional Review Committee (PRC) in accordance with applicable regulations, guidance documents, and internal policies/SOPs. The Director works cross functionally to understand commercial strategy and helps to provide compliant solutions.

Roles & Responsibilities

1. Provide regulatory guidance and review for promotional, disease state, and unbranded patient and market access materials
2. Review materials in Veeva Vault and actively participate in PRC meetings.
3. 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
4. Review and interpret enforcement actions, keeping current with industry changes relating to advertising and promotion, interpreting new FDA Guidance to Industry documents, and, as applicable, evaluating related internal policies/best practices and processes. Communicate to cross-functional team as appropriate.
5. Develop and implement regulatory ad promo strategy and managing complex negotiations with internal and external stakeholders.
6. Mentor junior members of the Regulatory Affairs Advertising & Promotion Team.
7. Serve as backup for Executive Director during peek volume times and out of office times
8. Serve as backup for Director of Advertising & Promotion Operations in management of 2253 process

Education & Licenses and Experience

Bachelor’s degree in scientific discipline and 8-10 years of related experience, or the equivalent combination of education and experience.

Competencies & Skills

• Strong understanding of the regulatory requirements for the promotion of prescription drugs
• Experienced reviewer of promotional material intended for HCPs and patients
• Knowledgeable about the use of social media in communications on prescription drugs
• Experienced in use of Veeva Vault for materials review
• Demonstrated ability to understand study design and product data
• Demonstrated ability to collaborative cross functionally, ensuring compliance while aligning with commercial strategy
• Ability to work in a fast-paced, dynamic environment with little supervision
• Ability to adapt well under pressure
• Ability to prioritize and manage multiple priorities and responsibilities simultaneously and follow-through on issues in a timely manner
• Effective verbal and written communication skills
• Proficient in the use of business productivity software (Excel, Word, PowerPoint, etc.) and review software (Veeva Vault PromoMats)

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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