Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Global Medical and Promotional Regulatory Affairs.

Key Responsibilities

• Lead the promotional material review committee for assigned products in the US
• Provide regulatory advice and ensure compliance of promotional materials with FDA regulations
• Serve as the Promotional Regulatory Affairs lead for new product launches and manage interactions with FDA/OPDP

Required Qualifications

• B.S or B.A. degree in a scientific discipline or equivalent; advanced degree preferred
• Substantial pharmaceutical industry experience in regulatory affairs, particularly in advertising and promotion
• Experience with oncology and new product launch support is strongly preferred
• Strong understanding of FDA regulations and guidelines
• Proven judgment and decision-making skills