Massachusetts Licensed Regulatory Director

Job Summary

Empowered to serve as an internal expert on FDA regulations, the full-time Massachusetts Licensed Regulatory Director will provide strategic oversight for promotional materials related to complex products, ensuring compliance while collaborating with cross-functional teams in a virtual environment.

Key responsibilities

• Serve as an internal expert on FDA regulations and oversee the regulatory compliance of promotional materials for assigned products
• Mentor and develop staff while chairing promotional review meetings and collaborating with various departments on commercial campaigns
• Interpret complex regulatory issues and provide strategic guidance to mitigate risks and support product development initiatives

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 pharmaceutical/biologic advertising and promotion
• Experience managing major regulatory filings and providing guidance to drug development teams
• Regulatory Affairs Certification (RAC) is desirable