What are the responsibilities and job description for the Executive Director, Regulatory Affairs position at Trebla Talent?
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.