Executive Director, Regulatory Affairs (AdPromo)

Role Summary

Executive Director of Advertising & Promotion - Regulatory Affairs for drug and device products, primarily in the US with support for Canada. Responsible for ensuring promotional materials comply with regulatory agency requirements.

Responsibilities

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

Qualifications

• Bachelor’s degree in science or health-related discipline required (Advanced degree PhD, MD, MS, PharmD preferred).
• Minimum 15 years of regulatory affairs in product advertising and promotion management experience.
• GI experience preferred.
• Broad knowledge of the pharmaceutical industry; demonstrated commitment to continuous learning and process improvement.
• Detail-oriented with the ability to assess documents for accuracy and consistency.
• 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.
• Excellent oral and written communication skills.

Education

• As listed in Qualifications (Bachelor’s required; advanced degrees preferred).