Senior Vice President, Regulatory Affairs

Senior Vice President, Regulatory Affairs

Location:

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

Reports to:

CEO

My 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:
The Senior Vice President, Regulatory Affairs, will serve as a critical member of the Executive Leadership Team. Reporting directly to the CEO, this leader will shape and execute global regulatory strategy, ensuring excellence in regulatory submissions, approvals, and compliance across commercial products, clinical development, and pipeline expansion. In this role, you will be responsible for guiding innovation, scaling a growing organization, and shaping the next phase of its growth.

Key Responsibilities

• Define and execute a comprehensive US and global regulatory strategy aligned with growth objectives and mission in musculoskeletal pain and adjacencies.
• Provide proactive guidance to the CEO, ELT, and Board of Directors on regulatory risks, opportunities, and evolving landscapes.
• Represent as the primary regulatory voice in key discussions with the FDA, EMA, and other global health authorities.
• Evaluate and strengthen regulatory processes and talent by attracting and onboarding top-tier industry leaders as needed to elevate organizational performance.

Regulatory Excellence

• Oversee and ensure the timely and high-quality submission of regulatory documents for both commercial products and innovative pipeline programs.
• Drive strategies for innovative pathways to support expedited development and approval of new therapies, including gene therapy initiatives.
• Support effective lifecycle management for commercial products, including label expansions, line extensions, and post-marketing requirements.

Organizational Impact

• Lead and develop a high-performing regulatory organization capable of scaling with pipeline and commercial growth.
• Partner cross-functionally with R&D, Tech Ops, Quality, Medical, and Commercial to ensure alignment and collaboration.
• Embed a culture of innovation, collaboration, and accountability throughout the Regulatory Affairs function.

Education & Experience

• Advanced degree (PhD, Pharm
  
  D, MD, or equivalent) in life sciences, pharmacy, or medicine.
• 15+ years of progressive regulatory leadership experience in the biopharma industry, with a blend of development and commercial-stage exposure.
• Demonstrated success in leading and scaling regulatory organizations during phases of significant growth.
• Expert working knowledge of regulations and specific experience in the area of new product development, advertising and promotion, and the ability to support multiple commercial products.
• Proven track record in securing regulatory approvals for small molecules, biologics, and preferably combination products/devices.
• Experience interacting directly with FDA, EMA, and other health authorities at senior levels.
• Modality
  
  Experience:
  
  Deep understanding of small molecules and biologics; exposure to gene therapy is highly desirable.
• Therapeutic
  
  Experience:
  
  Experience in Musculoskeletal Pain, CNS, Rheumatology, or adjacent therapeutic areas preferred.
• Ability to serve as an enterprise-wide thought leader, balancing innovation, compliance, and operational excellence.
• Strong communication, negotiation, and problem-solving skills with the ability to influence at the ELT and Board levels.