Senior Director, Regulatory Affairs Strategy

Were working with a well-backed biotech with a strong and growing oncology pipeline, looking to bring on a Senior Director into their global regulatory team.

This is a senior, visible role where youll take ownership of regulatory strategy across key late-stage programs. The focus is on leadership, influencing cross-functional teams, and driving programs through to approval and beyond.

Youll be leading global regulatory strategy across one or more oncology assets, primarily in late-stage development, acting as the Global Regulatory Lead and working closely with clinical, CMC, commercial and senior leadership teams. The role involves owning the regulatory plan end to end, from development through submission and launch readiness, as well as leading interactions with Health Authorities, including the FDA.

Theres a strong execution piece as well, with responsibility for major submissions such as NDA, BLA and MAA, making sure everything is delivered on time and to a high standard. Youll be working across regions to ensure a consistent global strategy, while also supporting broader business decisions with clear regulatory input and risk assessment. There is also an expectation to mentor and guide more junior team members where appropriate.

Theyre looking for someone with a solid background in regulatory affairs within pharma or biotech, ideally 12+ years, with strong experience across late-stage programs and major filings. Oncology experience is important here, alongside a good understanding of global regulations including FDA and EMA. The right person will be comfortable operating at a strategic level but still close enough to the detail, and able to work across teams and influence without relying on hierarchy.

Its a chance to step into a genuine leadership role on high-priority programs within a company thats investing heavily in oncology. Youll have real input into strategy and clear visibility with senior leadership.