Associate Director, Regulatory Affairs

Responsibilities

• Lead drug development programs with emphasis on US and global regulatory strategy


• Manage Clinical Trial Applications, Market Applications, and amendments


• Collaborate with functional leaders to create optimal development paths for product candidates


• Lead cross-functional teams in developing strategic briefing packages for health authority meetings


• Ensure global regulations and guidelines for biologics or ATMPs are incorporated into decision making


• Ensure submission documents are of the highest quality in content, organization, and accuracy

Requirements

• BS degree in life sciences


• 10+ years of regulatory affairs experience (with BS), 8 years (with MS), or 5+ years (with PhD)


• Late-stage experience in oncology drug development


• Experience negotiating clinical-regulatory aspe...