Director Regulatory Affairs Advertising & Promotion

Role: Director of Regulatory Affairs Advertising & Promotion, leading regulatory review and guidance for promotional and non-promotional materials in accordance with FDA regulations and internal policies. Responsibilities: review materials in Veeva Vault, participate in PRC meetings, interpret industry guidance, develop regulatory promotional strategies, and mentor team members. Serves as backup for senior leadership during peak periods and manages complex stakeholder negotiations. Requirements: Bachelor's degree in a scientific discipline, 8-10 years of related experience, strong understanding of prescription drug promotion regulations, and proficiency in Veeva Vault and regulatory review processes. Preferred: experience with social media communication regulation, study design comprehension, and cross-functional collaboration skills. High-Value: focus on prescription drug promotion, regulatory review, and compliance in a fast-paced biotech environment. Work Setup: not specified; based on industry norms, likely office or hybrid.