Senior Director, Regulatory Affairs Strategy

About the role

This is a senior, visible leadership position within the global regulatory team, focused on owning regulatory strategy for key late-stage oncology programs. You will act as the Global Regulatory Lead, driving programs through approval and beyond by influencing cross-functional teams and working closely with clinical, CMC, commercial, and senior leadership. The role involves end-to-end ownership of the regulatory plan, from development through submission and launch readiness, as well as leading interactions with Health Authorities, including the FDA.

You will be responsible for major submissions such as NDA, BLA, and MAA, ensuring timely and high-quality delivery. The position also requires developing a consistent global regulatory strategy across regions and supporting broader business decisions with clear regulatory input and risk assessment. Mentoring junior team members is expected.

Responsibilities

• Lead global regulatory strategy for one or more late-stage oncology assets as the Global Regulatory Lead.
• Own the end-to-end regulatory plan, from development through submission and launch readiness.
• Drive major submissions (e.g., NDA, BLA, MAA) to ensure on-time, high-quality delivery.
• Lead interactions with Health Authorities, including the FDA and EMA.
• Collaborate with cross-functional teams (clinical, CMC, commercial, senior leadership) to align regulatory strategy.
• Ensure a consistent global regulatory strategy while addressing regional requirements.
• Provide regulatory input and risk assessment to support business decisions.
• Mentor and guide junior team members as appropriate.

Requirements

• 12+ years of experience in regulatory affairs within pharma or biotech.
• Strong background in late-stage programs and major filings (e.g., NDA, BLA, MAA).
• Oncology experience is critical.
• In-depth understanding of global regulations, including FDA and EMA.
• Ability to operate strategically while remaining detail-oriented.
• Strong leadership and influence across teams, without relying on hierarchy.

About the company

A well-backed biotech with a strong and growing oncology pipeline, investing heavily in late-stage programs. This role offers genuine leadership opportunities on high-priority assets, with direct visibility and input into strategy at the senior leadership level.