Associate Director of Regulatory Affairs

Job Summary

Leading drug development programs, the full-time remote Associate Director of 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 and negotiate optimal development paths for product candidates
• Plans and manages Clinical Trial Applications and Market Applications, ensuring timely execution of regulatory development plans
• Leads cross-functional teams in preparing strategic briefing packages and health authority interactions

Required qualifications

• BS degree in life sciences required
• Minimum 5 years of regulatory affairs experience with a doctorate, 8 years with a Master's, or 10 years with a Bachelor's degree
• Experience in late-stage oncology drug development
• Proven ability to create and negotiate clinical-regulatory aspects of oncology programs with health authorities
• Strong skills in writing and editing high-quality clinical-regulatory documents