Massachusetts Licensed Regulatory Director

Job Summary

Serving as an internal expert on FDA regulations, the full-time Massachusetts Licensed Regulatory Director will provide strategic oversight for promotional materials related to complex drug and biologic products, ensuring compliance while collaborating with cross-functional teams.

Key responsibilities

• Provide regulatory strategic oversight for promotional materials and ensure compliance with FDA regulations
• Mentor and develop staff while chairing promotional review meetings and collaborating with various departments
• Interpret complex regulatory issues and provide guidance on promotional strategies and risk mitigation

Required qualifications

• Bachelor's Degree in life science or equivalent; advanced degree (PharmD, PhD, MS, MBA, JD) preferred
• Minimum of 5 years' experience in Regulatory Affairs, with at least 3 years focused on Advertising and Promotion
• Knowledge of regulations specific to advertising and promotion of pharmaceutical/biologic products
• Experience managing major regulatory filings and providing guidance to drug development teams
• Regulatory Affairs Certification (RAC) desirable