California Licensed Regulatory Affairs Director

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 manage the review and approval process for promotional materials
• Develop regulatory strategies and lead interactions with FDA for assigned products

Required Qualifications

• B.S or B.A. degree in a scientific discipline or equivalent
• Advanced degree in a scientific discipline (e.g., PharmD) strongly preferred
• Substantial pharmaceutical industry experience in regulatory affairs advertising and promotion
• Experience with Oncology and new product launch support is strongly preferred
• Strong understanding of FDA regulations and guidelines