Senior Vice President of Regulatory Affairs

Job Summary

A company is looking for a Senior Vice President, Regulatory Affairs.

Key Responsibilities

• Develop and own the global regulatory strategy through NDA submission and approval
• Lead the preparation, submission, and lifecycle management of major regulatory filings
• Serve as the primary regulatory voice in cross-functional teams and as the main contact for regulatory authorities

Required Qualifications and Education

• Advanced degree preferred: PharmD, PhD, MD, or equivalent in a scientific or healthcare discipline
• 12+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• Proven track record of successful NDA submissions and interactions with regulatory authorities
• Preferred prior experience working at the FDA
• Strong cross-functional leadership experience, particularly with Clinical Development and CMC teams