Director of Regulatory Affairs

Job Summary

Leading drug development programs, the remote Director of Regulatory Affairs will manage global regulatory strategy, oversee regulatory submissions, and interact with global regulatory authorities while ensuring high-quality documentation and compliance with evolving regulations in oncology.

Key responsibilities

• Collaborates with functional leaders to create optimal development paths and execute clinical-regulatory development plans
• Plans and manages Clinical Trial Applications and Market Applications, ensuring timely submission and quality documentation
• Leads cross-functional teams in preparation for health authority meetings and incorporates regulatory expectations into program decision-making

Required qualifications

• BS degree in life sciences
• Minimum 10 years of experience in regulatory affairs, specifically in oncology drug development
• Proven ability to create and negotiate clinical-regulatory documents
• Experience managing multiple projects and submissions simultaneously
• Strong organizational and planning skills with high attention to detail