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 is a hands-on strategic role where you’ll sit on cross-functional program teams as the Regulatory Lead, supporting both early development programs moving into the clinic and more advanced assets heading toward registration. It’s a mix of strategy, execution and influence, with good exposure across the organization.
You’ll be responsible for shaping and driving global regulatory strategy across pipeline and, where applicable, marketed products. That includes identifying smart, data-driven approaches, thinking ahead on risks, and keeping a close eye on how the regulatory and competitive landscape is evolving. There’s also a strong execution component, leading the planning and delivery of submissions and making sure everything aligns with both internal objectives and Health Authority expectations.
The role involves leading interactions with regulators, interpreting feedback and making sure that’s clearly translated back into the business. You’ll be working closely with internal stakeholders across functions, representing Regulatory in governance settings and helping to ensure alignment at a senior level. There’s also an internal leadership element, contributing to the broader regulatory group and sharing best practices across the team.
They’re looking for someone with a solid background in regulatory affairs within biotech or pharma, typically around 10+ years, with experience operating as a Regulatory Lead on development programs. A strong understanding of the full drug development lifecycle is important, along with the ability to translate strategy into practical plans and timelines. Neurology experience is strongly preferred given the focus of the pipeline.
The right person will be comfortable working cross-functionally, able to communicate clearly with both technical and non-technical stakeholders, and confident managing multiple priorities in a fast-moving environment. It suits someone who enjoys being close to the science but also wants to have a broader strategic impact across programs.
