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Executive Director, Regulatory Affairs

Job

Trebla Talent

Remote

Full-Time

Posted 1 week ago (Updated 6 days ago) • Actively hiring

Expires 7/7/2026

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Job Description

Executive Director, Regulatory Affairs at Trebla Talent Executive Director, Regulatory Affairs at Trebla Talent in Milton Village, Massachusetts Posted in about 6 hours ago.
Type:
full-time
Job Description:
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.