Director Regulatory Strategy

About the role

We’re working with a growing biotech in the Boston area, focused within neurology, that’s building out its regulatory strategy team and looking to bring in a Director‑level hire. This hands‑on strategic position serves as the Regulatory Lead on cross‑functional program teams, supporting early development programs moving into the clinic as well as more advanced assets heading toward registration. The role blends strategy, execution, and influence, offering broad exposure across the organization.

Responsibilities

• Shape and drive global regulatory strategy across the pipeline and, where applicable, marketed products.
• Identify data‑driven approaches, anticipate risks, and monitor the evolving regulatory and competitive landscape.
• Lead the planning and delivery of regulatory submissions, ensuring alignment with internal objectives and Health Authority expectations.
• Manage interactions with regulators, interpret feedback, and translate outcomes back to the business.
• Collaborate with internal stakeholders across functions, represent Regulatory in governance settings, and ensure senior‑level alignment.
• Contribute to the broader regulatory group, sharing best practices and providing internal leadership.

Qualifications

• 10+ years of regulatory affairs experience in biotech or pharma, with a track record as a Regulatory Lead on development programs.
• Strong understanding of the full drug development lifecycle and ability to translate strategy into practical plans and timelines.
• Neurology therapeutic experience strongly preferred.
• Proven ability to work cross‑functionally and communicate clearly with both technical and non‑technical stakeholders.
• Demonstrated skill in managing multiple priorities in a fast‑moving environment.
• Passion for staying close to the science while delivering broader strategic impact across programs.