Senior Director of Regulatory Affairs

Job Summary

A company is looking for a Senior/Executive Director, Regulatory Affairs.

Key Responsibilities

• Represent regulatory on cross-functional teams and provide leadership for regulatory deliverables
• Lead planning and support the development of global regulatory submission documents
• Serve as primary contact with Health Authorities and maintain expert knowledge in regulations

Required Qualifications

• Bachelor's degree with a minimum of 12 years of experience in Regulatory Affairs
• Demonstrated track record of successful interactions with FDA and other Health Authorities
• Expert understanding of scientific principles and regulatory requirements for global drug development
• Experience in preparing regulatory filings, including IND/CTAs and briefing documents
• Strong project management skills and ability to work in a fast-paced environment