Senior Program Director, Commercial Regulatory Affairs

Senior Program Director, Commercial Regulatory Affairs at System One in South San Francisco, San Mateo County leads cross‑functional program review committees to drive successful product launches.

About the Role

This full‑time position focuses on overseeing Program Review Committees (PRCs) for complex product introductions, ensuring regulatory compliance while coordinating activities across multiple functions. The role reports to senior leadership and supports the commercialization strategy for the company’s pipeline.

What You'll Do

• Independently lead and facilitate Program Review Committees, serving as the primary decision‑maker for assigned therapeutic or business areas.
• Manage end‑to‑end activities for complex product launches, including timeline development, risk assessment, and resource allocation.
• Collaborate with regulatory, clinical, quality, marketing, and supply chain teams to align PRC outcomes with commercial objectives.
• Develop and maintain PRC charters, standard operating procedures, and reporting metrics to ensure consistency and transparency.
• Identify regulatory risks early and drive mitigation strategies that support timely market entry.
• Prepare and present PRC recommendations to executive stakeholders, influencing go/no‑go decisions.
• Monitor key performance indicators and continuously improve PRC processes based on lessons learned.

What We're Looking For

• Bachelor’s or advanced degree in life sciences, pharmacy, regulatory affairs, or a related discipline.
• Extensive experience in commercial regulatory affairs, with a proven track record of leading product launch committees.
• Strong understanding of FDA regulations, global regulatory requirements, and lifecycle management principles.
• Exceptional program management skills, including the ability to juggle multiple high‑priority initiatives simultaneously.
• Excellent communication and interpersonal abilities, capable of influencing cross‑functional partners at all levels.
• Analytical mindset with experience using data to assess risks, timelines, and resource needs.
• Demonstrated leadership in fostering collaborative environments and driving consensus.

About System One

System One is a workforce solutions partner that connects specialized talent with innovative organizations across the life sciences, technology, and engineering sectors. The company leverages deep industry expertise to deliver contingent staffing, managed services, and direct hire solutions that help clients accelerate product development and achieve strategic goals.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.