Regulatory Affairs Associate Director

Job Summary

Leading drug development programs, the remote Associate Director, Regulatory Affairs will manage US and global regulatory strategies, submissions, and interactions with health authorities while ensuring high-quality documentation and compliance with evolving regulations.

Key responsibilities

• Collaborates with functional leaders to create optimal development paths and execute clinical-regulatory plans
• Plans and manages Clinical Trial Applications and Market Applications, ensuring timely submissions
• Leads cross-functional teams in developing strategic briefing packages for health authority meetings

Required qualifications

• BS degree in life sciences required
• Minimum 10 years' experience in regulatory affairs with a Bachelor's degree, 8 years with a Master's degree, or 5+ years with a PhD
• Experience in late-stage oncology drug development
• Proven ability to create and negotiate clinical-regulatory documents with health authorities
• Strong organizational skills with the ability to manage multiple projects simultaneously