Director Regulatory Affairs Advertising & Promotion

About the role

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.

Responsibilities

• 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
• Mentor junior members of the Regulatory Affairs Advertising & Promotion Team
• Serve as backup for Executive Director during peak volume times and out of office times
• Serve as backup for Director of Advertising & Promotion Operations in management of 2253 process

Qualifications

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

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 collaborate 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)