Director, Regulatory Affairs, Advertising & Promotion

Proclinical Staffing; United States; Remote; USD 180,000 - 220,000; Full time

Job summary

Proclinical is seeking a Director, Regulatory Affairs, Advertising & Promotion for a dermatology-focused biotechnology company based in California. This remote-based role requires residency in the United States and leadership in promotional regulatory review.

The candidate will guide cross-functional teams, review materials for PRC, and stay current with FDA guidance and enforcement actions to ensure compliant communications across products and therapeutic areas.

Qualifications

• Bachelor’s degree in scientific discipline and 8-10 years of related experience.
• Strong understanding of regulatory requirements for promotion of prescription drugs.
• Experience reviewing promotional material for HCPs and patients.
• Knowledge of social media use in prescription drug communications.
• Experience using Veeva Vault for materials review.

Responsibilities

• Provide regulatory guidance and review for promotional, disease state, and non-promotional materials.
• Review materials in Veeva Vault and participate in PRC meetings.
• Evaluate perspectives from Commercial, Legal/Compliance, Medical and provide regulatory guidance across teams.
• Monitor enforcement actions and FDA guidance to inform internal policies and processes.
• Develop and implement regulatory ad promo strategies and manage complex negotiations with stakeholders.

Skills

Regulatory affairs

Promotional review

Cross-functional collaboration

FDA guidance interpretation

Social media pharma comms

Education

Bachelor's degree in life sciences

Tools

Veeva Vault

Job description

Director, Regulatory Affairs, Advertising & Promotion – Permanent – Remote Based

Proclinical is seeking a Director, Regulatory Affairs, Advertising & Promotion for an exciting and growing dermatology-focused biotechnology company based in California.

Primary Responsibilities:

In this role, you will be responsible for providing the regulatory review on the Promotional Review Committee (PRC) in accordance with applicable regulations, guidance documents, and internal policies/SOPs. You will work cross functionally to understand commercial strategy and help to provide compliant solutions.

The position is remote based. Candidate must reside in the United States.

Skills & Requirements:

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

The Director, Regulatory Affairs, Advertising & Promotion will:

• Provide regulatory guidance and review for promotional, disease state, and unbranded patient and market access materials.
• Review materials in Veeva Vault and actively participate in PRC meetings.
• 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.
• 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.
• Develop and implement regulatory ad promo strategy and managing complex negotiations with internal and external stakeholders.

Proclinical Staffing is an equal opportunity employer.