Executive Director, Regulatory Affairs

Role: Executive Director, Regulatory Affairs

Location: Boston, MA (Hybrid)

About the Organization

Our client is a clinical-stage biotechnology company focused on developing innovative therapies for patients with cancer and other serious diseases. With both commercial and late-stage development programs, the organization offers the unique opportunity to contribute to multiple stages of the product lifecycle while helping shape the future direction of a growing biotech company.

Role Description

Our client is seeking an Executive Director of Regulatory Affairs to provide strategic regulatory leadership for a late-stage development portfolio, including a Phase 3 oncology program and supportive care initiatives. This individual will serve as a key strategic partner across Regulatory Affairs, Clinical Development, Biostatistics, and executive leadership, helping to shape global regulatory strategy, influence development decisions, and drive successful regulatory outcomes.

Key Responsibilities

• Lead global regulatory strategy for late-stage development programs, including Phase 3 assets and registration-enabling activities.
• Drive regulatory strategy for NDA and/or BLA submissions and related agency interactions.
• Lead regulatory assessment of development plans, clinical trial designs, endpoints, and health authority requirements.
• Contribute to regulatory infrastructure development, process optimization, and organizational best practices.
• Mentor and influence colleagues across the organization while fostering a collaborative, solutions-oriented culture.

Qualifications

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 15+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry.
• Significant experience developing and executing global regulatory strategy for late-stage oncology programs.
• Demonstrated success leading NDA and/or BLA submissions.
• Strong executive presence, communication skills, and scientific acumen.

Remote candidates in the easter timezone will also be considered.