Senior Manager, Regulatory Affairs

Job Summary

Leading the regulatory review of advertising and promotional materials, the full-time Senior Manager, Regulatory Affairs will ensure compliance with FDA regulations while collaborating with cross-functional teams in a Boston-based role, with remote options available for the right candidate.

Key responsibilities

• Lead the regulatory review and approval of advertising and promotional materials for assigned US products
• Serve as a key regulatory representative on the Promotional Review Committee (PRC) and Medical Scientific Review Committee (MSRC)
• Oversee the preparation and timely submission of FDA Form 2253 for promotional materials

Required qualifications

• Bachelor's degree in a scientific or healthcare field
• 5+ years of experience in Regulatory Affairs, specifically in advertising and promotion within a biotech/pharmaceutical setting
• Strong expertise in FDA regulations and guidance documents
• Proficiency with electronic document management systems and promotional review platforms
• Demonstrated ability to interpret complex clinical study reports for compliant promotional messaging