Associate Director of Regulatory Affairs

Job Summary

Leading global regulatory strategy for drug development programs, the full-time Associate Director of Regulatory Affairs will manage regulatory submissions and interactions with international health authorities while working remotely.

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 high-quality submission documents
• Leads cross-functional teams in developing strategic briefing packages for health authority meetings

Required Qualifications

• BS degree in life sciences required
• Minimum of 5 years' experience in regulatory affairs with an advanced degree or 7 years with a BS
• Experience in late-stage oncology drug development
• Proven ability to create and negotiate clinical-regulatory aspects with health authorities Ex-US
• Strong skills in writing and editing high-quality clinical-regulatory documents