Regulatory Director - Global Lead - EU MAA and US - #2165902

Director, Global Regulatory Affairs - 6-month contract, goal to go perm after 6 months

Lead Regulatory Strategy for Innovative Immunology / Oncology Programmes

Our client is an ambitious and growing biotechnology company with a promising immunology / oncology pipeline and a strong commitment to advancing innovative therapies for patients with high unmet need.

As Director, Global Regulatory Affairs, you will serve as the Global Regulatory Lead for assigned development programmes, providing strategic regulatory leadership from early clinical development through to late-stage development and registration planning. You will work closely with cross-functional stakeholders and senior leadership to shape global regulatory strategy and drive successful interactions with health authorities worldwide.

This is an excellent opportunity for a regulatory professional who enjoys influencing programme direction, solving complex development challenges and operating as a key strategic partner within a collaborative biotech environment.

What We're Looking For

• Significant Regulatory Affairs experience within biotechnology or pharmaceutical drug development.
• Previous experience leading or playing a key leadership role in a Marketing Authorisation Application (MAA) and/or BLA submission.
• Proven experience acting as the Global Regulatory Lead (GRL) or regulatory lead for development programmes.
• Demonstrated experience developing and executing global regulatory strategy across the product life cycle.
• Experience preparing for and leading interactions with major Health Authorities, including the FDA and EMA.
• Strong understanding of clinical development, regulatory pathways and registration strategy.
• Experience translating health authority feedback into development and regulatory plans.
• Ability to influence cross-functional teams and senior stakeholders within a matrix environment.

Why Join?

• Take ownership of regulatory strategy for high-profile development programmes.
• Influence key decisions that shape the future of innovative oncology therapies.
• Work within a science-led and collaborative biotechnology environment.
• Gain significant visibility with senior leadership and programme teams.
• Competitive salary, bonus and comprehensive benefits package.