Vice President of Regulatory Affairs

Job Summary

As the senior regulatory leader, the full-time remote Vice President of Regulatory Affairs will develop and execute global regulatory strategies for innovative therapeutics and devices, ensuring compliance and advancing product development from preclinical stages through commercialization.

Key Responsibilities

• Develop and execute innovative regulatory strategies to maximize development efficiency and approval probability
• Serve as the primary regulatory contact with FDA and other global health authorities
• Lead all regulatory aspects of product development, including preparation and submission of INDs, NDAs, and BLAs

Required Qualifications

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent) and/or Regulatory Affairs Certification (RAC)
• Minimum 15 years of regulatory affairs experience in pharmaceutical and/or biotechnology companies
• Significant experience leading FDA interactions and major regulatory submissions
• Demonstrated success in obtaining IND clearances and advancing development programs
• Strong understanding of clinical development, CMC, and commercialization requirements