Massachusetts Licensed Regulatory Affairs Director

Job Summary

A company is looking for an Associate Director, Global Regulatory Affairs, Advertising and Promotion.

Key Responsibilities

• Act as the Subject Matter Expert for assigned products and projects in advertising and promotion regulatory affairs
• Provide regulatory guidance during the development, review, approval, and implementation of medical and commercial materials
• Serve as the CMRP Meeting Chair, facilitating communication and decision-making within the team

Required Qualifications

• BSc Degree preferred; BA accepted
• 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience
• Understanding of ABPI, EFPIA, and other international codes regarding advertising and promotion
• Experience in the prescription medicine promotion development and review process
• Proven experience in regulatory affairs, particularly in advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards