Job Details

Job Title: Senior Vice President, Regulatory Affairs (Consultant)

Job Number: 36983

Location: Remote

Job Description

Our client is a late clinical-stage biopharmaceutical company advancing an innovative small-molecule therapeutic with the potential to address a significant unmet medical need. The organization is preparing for Phase 3 development and eventual NDA/aNDA submission and seeks an accomplished Senior Vice President, Regulatory Affairs Consultant to provide strategic oversight and executive-level guidance during this pivotal stage.

This highly visible role will shape regulatory strategy, optimize submission readiness, and ensure cohesive alignment across regulatory, clinical, and CMC functions. The ideal consultant brings extensive NDA experience, sound judgment, and a proven record of collaboration with executive teams in small to mid-sized biopharma settings.

Responsibilities

• Lead the design and execution of the global regulatory strategy to support late-stage clinical development and NDA/aNDA submission.
• Serve as the principal regulatory advisor to executive leadership, providing guidance on study design, data integration, and Health Authority expectations.
• Direct preparation for FDA and global agency interactions, including End-of-Phase 2, Type C, and Pre-NDA meetings; oversee briefing documentation and communication strategy.
• Conduct regulatory gap assessments across clinical, nonclinical, and CMC functions to ensure submission completeness and compliance.
• Advise on labeling development, safety database requirements, and risk management planning consistent with regulatory precedent.
• Oversee the preparation, quality control, and integration of key regulatory deliverables, including IND amendments, annual reports, and NDA modules (particularly Modules 2 and 3).
• Guide and coordinate efforts across internal stakeholders, external consultants, and CROs to maintain alignment, efficiency, and submission quality.
• Monitor regulatory intelligence and evolving guidance, applying insights to development strategy and program positioning.

Qualifications

• 15+ years of progressive leadership experience in Regulatory Affairs within the biopharmaceutical industry.
• Proven success in leading or significantly contributing to NDA, sNDA, or aNDA submissions, and direct experience managing FDA interactions (EMA experience preferred).
• Strong understanding of ICH, FDA, and EMA regulatory frameworks governing small‑molecule development and marketing authorization.
• Deep familiarity with late‑stage clinical operations, CMC validation, and regulatory documentation standards.
• Exceptional communication, strategic thinking, and cross‑functional collaboration skills.
• Advanced scientific or regulatory degree (PharmD, PhD, MS, or equivalent) preferred.

Engagement Terms

• Duration: 6‑month initial consulting term, with potential extension through NDA/aNDA submission.
• Commitment: Approximately 10–20 hours per month (flexible, milestone‑driven).
• Compensation: Hourly consulting rate and equity eligibility based on experience and engagement scope.