Senior Vice President, Regulatory Affairs

About This Role

This executive leadership role is responsible for owning and shaping the global regulatory strategy for commercial products, lifecycle management, and pipeline development for a commercial-stage biopharmaceutical organization. The Senior Vice President will serve as a key advisor to the executive team and Board on regulatory matters.

Responsibilities

• Define and execute comprehensive U.S. and global regulatory strategies aligned with corporate growth objectives
• Serve as a trusted advisor to the CEO, Executive Leadership Team, and Board of Directors on regulatory risk, opportunity, and evolving global requirements
• Act as the primary regulatory spokesperson with the FDA, EMA, and other global health authorities
• Evaluate, strengthen, and scale regulatory capabilities, processes, and talent as the organization grows
• Oversee timely, high-quality regulatory submissions for commercial products and pipeline programs
• Lead strategies to expedite development and approval for innovative therapies, including emerging modalities
• Guide lifecycle management initiatives, including label expansions, line extensions, and post-marketing commitments
• Ensure regulatory compliance across development, commercialization, and promotional activities
• Build, lead, and develop a high-performing global Regulatory Affairs organization
• Partner closely with R&D, Clinical, CMC/Tech Ops, Quality, Medical, Legal, and Commercial teams

Requirements

• 15+ years of progressive regulatory leadership experience within the biopharmaceutical industry
• Proven success leading regulatory strategy for both development-stage and commercial products
• Strong experience with FDA and international health authority interactions at senior levels
• Track record of regulatory approvals for small molecules and biologics
• Demonstrated success in leading and scaling regulatory organizations during phases of significant growth
• Executive presence with strong communication, negotiation, and influencing skills

Qualifications

• Advanced degree (PhD, PharmD, MD, or equivalent) in life sciences, pharmacy, or medicine
• 15+ years of progressive regulatory leadership experience within the biopharmaceutical industry

Nice to Have

• Experience with combination products and devices
• Exposure to gene therapy or emerging modalities
• Experience in musculoskeletal pain, CNS, rheumatology, or adjacent therapeutic areas