California Licensed Regulatory Affairs Director

Job Summary

A company is looking for an Associate Director, Global Medical & Promotional Regulatory Affairs.

Key Responsibilities

• Lead the promotional material review committee for assigned products and ensure compliance with FDA regulations
• Provide regulatory advice and support for promotional materials, including submissions to the Office of Prescription Drug Promotion
• Collaborate with cross-functional teams to develop regulatory strategies and ensure timely review of materials

Required Qualifications

• B.S. or B.A. degree in a scientific discipline or equivalent experience in the pharmaceutical industry
• Substantial experience in advertising and promotional material review
• Strong understanding of FDA regulations and guidelines
• Advanced degree in a scientific discipline (e.g., PharmD) is preferred
• Demonstrated judgment and decision-making skills