Vice President, Regulatory Affairs

Job Summary

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

Key Responsibilities:

• Develop and lead integrated global regulatory strategies for all pipeline programs
• Oversee planning, authoring, review, and submission of regulatory dossiers
• Build and mentor a high-performing regulatory team while ensuring compliance with regulatory standards

Qualifications:

• Advanced degree in life sciences or related discipline; equivalent experience may be considered
• 15+ years of experience in biopharmaceutical regulatory affairs, particularly in small or mid-size biotech
• Proven track record of leading major global submissions through acceptance and approval
• Strong understanding of global regulatory frameworks across early development and post-approval lifecycle management
• Demonstrated ability to build and lead teams in a fast-paced biotech environment