About the Role

An innovative biotechnology company is seeking an experienced regulatory professional to lead global regulatory strategy across a portfolio of clinical-stage programmes.This is a highly strategic role, providing regulatory leadership across development activities and acting as the key regulatory partner to cross-functional teams. The successful candidate will be responsible for driving regulatory strategy across the US, Europe and international markets whilst supporting development programmes from early clinical development through to registration.
Key Responsibilities

• Lead and execute global regulatory strategies for assigned development programmes in Oncology.
• Provide regulatory leadership across FDA, EMA and international markets.
• Act as the regulatory representative on cross-functional project teams.
• Lead interactions with Health Authorities, including FDA and EMA.
• Provide strategic input into clinical development plans and regulatory pathways.
• Support preparation and review of key regulatory submissions.
• Assess regulatory risks and develop mitigation strategies.
• Ensure regulatory activities are aligned with programme objectives and timelines.

Experience Required

• Significant Regulatory Affairs experience within biotechnology or pharmaceutical development.
• Proven experience leading global regulatory strategy for innovative products.
• Strong experience supporting clinical development programmes from Phase I through Phase III.
• Hands-on strategic experience with IND, CTAs and BLA submissions is essential.
• Strong knowledge of FDA and EMA regulatory requirements.
• Experience leading Health Authority meetings and regulatory interactions.
• Excellent stakeholder management and communication skills.
• Ability to influence programme strategy within a cross-functional environment.

Ideal Background

Suitable for an experienced regulatory leader with a strong track record in global clinical development, regulatory strategy, FDA and EMA interactions, and major regulatory submissions. Experience in oncology, biologics, immunology or other innovative therapeutic areas would be highly advantageous.