Executive Director, Regulatory Affairs (AdPromo)

Role Summary

Executive Director of Advertising & Promotion - Regulatory Affairs oversees the regulatory reviews and approvals of advertising and promotional labeling for prescription, over-the-counter, and cosmetic products, primarily in the US with support for Canada. The role ensures promotional materials comply with regulatory agency requirements and supports the company’s promotional objectives.

Responsibilities

• Manages Regulatory Promotional reviewers who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products; may review promotional materials and escalate as needed to ensure regulatory compliance while meeting promotional objectives.
• Provide guidance on proposed claims for products in development and the development of ISI and brief summaries.
• Regularly monitor regulatory compliance trends, interpret new regulations, guidance documents, and enforcement letters.
• Update staff and relevant teams regarding changes in the regulatory environment (FDA OPDP, PAAB, and other considerations); develop or revise procedures as needed.
• Review packages for regulatory advice and resolution of FDA/Canadian action letters; lead discussions with FDA OPDP and Canada PAAB.
• Coordinate company-wide ongoing regulatory training on issues pertaining to promotion of company products.
• Represent regulatory affairs in cross-functional prescription product promotional review teams; participate in development committees for processes and procedures relating to advertising and promotion.
• Interact with Legal, Compliance, and Medical Affairs regularly; collaborate with Quality on internal audits and CAPAs as needed.

Qualifications

• Required: Bachelor’s degree in science or health-related discipline; advanced degree (PhD, MD, MS, PharmD) preferred.
• Required: Minimum 15 years of regulatory affairs product advertising and promotion experience and people management experience.
• Preferred: GI experience.
• Required: Broad knowledge of the pharmaceutical industry; ability to contribute to continuous learning and process improvement; detail-oriented with strong accuracy and consistency assessment.
• Required: Strong interpersonal skills with the ability to influence others effectively; ability to work in a team environment; working knowledge of pharmaceutical and device development and approval processes.
• Required: Excellent oral and written communication skills.