Senior Principal Regulatory Consultant

Job Summary

Combining deep regulatory expertise with strong consulting experience, the full-time Senior Principal Regulatory Consultant will deliver high-impact regulatory strategies for C-level executives while working remotely, focusing on business development, client delivery, and team mentorship.

Key responsibilities

• Acts as a trusted advisor to pharmaceutical and biotech executives, providing expert regulatory guidance on complex development programs
• Generates new business and develops multi-year account strategies to strengthen client relationships and secure repeat engagements
• Provides strategic oversight across engagements, managing risk and ensuring quality in regulatory strategy outputs while mentoring team members

Required qualifications

• Minimum 15+ years of progressive regulatory experience in consulting and in-house biopharma roles
• Direct experience leading regulatory strategies across multiple stages and therapeutic areas
• Strong expertise in pre-IND through post-market regulatory activities and complex regulatory strategies
• PhD, MPH, or MS in life sciences, regulatory affairs, or related field; MBA or equivalent qualifications preferred
• Demonstrated ability to generate business and meet individual sales/revenue targets