Senior Vice President, Regulatory Affairs

Senior Vice President, Regulatory Affairs Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International

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Location: Hybrid - Parsippany, NJ (or) Brisbane, CA (Hybrid)

Reports to: Chief Executive Officer

Our client is a commercial-stage leader in non-opioid pain management and regenerative health solutions. They are dedicated to transforming patient care by delivering innovative therapies that reduce reliance on opioids, advance musculoskeletal pain treatments, and address significant unmet medical needs.

Position: This is a rare opportunity to step into a Chief Executive facing role and shape global regulatory strategy for a commercial-stage biopharmaceutical organization with a growing pipeline. As Senior Vice President, Regulatory Affairs, you will lead regulatory strategy across commercial products, lifecycle management, and development programs, while serving as a trusted advisor to the executive team and Board. The role offers meaningful influence, autonomy, and the chance to enable innovation at scale.

Strategic Leadership:

• 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.

Regulatory Excellence:

• 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.

Organizational Impact:

• 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.
• Foster a culture of accountability, collaboration, and innovation.

• Advanced degree (PhD, Pharm
  
  D, MD, or equivalent) in life sciences, pharmacy, or medicine.
• 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; experience with combination products and devices preferred.
• Exposure to gene therapy or emerging modalities is highly desirable.
• Experience in musculoskeletal pain, CNS, rheumatology, or adjacent therapeutic areas preferred.
• Executive presence with strong communication, negotiation, and influencing skills.

Executive

Full-time

Strategy/Planning and Project Management

Pharmaceutical Manufacturing

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