Regulatory Affairs Director Contract - Execution team

About the Role

I am supporting an Oncology biotechnology organisation seeking an experienced Regulatory Affairs leader to oversee the execution of global regulatory activities across a clinical-stage portfolio.

This role requires a strong people leader with proven experience delivering US and EU regulatory submissions, leading regulatory teams, and ensuring successful execution of regulatory strategies across multiple development programmes.

Key Responsibilities

• Lead, mentor and develop a team of Regulatory Affairs professionals.
• Drive the execution of regulatory strategies across US, EU and international markets.
• Oversee the preparation, review and delivery of regulatory submissions, including INDs, CTAs, BLAs and MAAs.
• Ensure high-quality, compliant and timely submission delivery.
• Partner with cross-functional teams to support development and regulatory objectives.
• Provide regulatory guidance, risk assessment and issue resolution throughout the submission process.
• Lead resource planning, workload allocation and team development.
• Support interactions with health authorities and manage regulatory commitments.
• Drive process improvements and operational excellence across the regulatory function.

Experience Required

• Significant Regulatory Affairs experience within biotech, pharmaceutical or CRO environments.
• Strong experience with US and EU regulatory submissions.
• Proven track record delivering INDs, CTAs, BLAs and MAAs.
• Experience leading and developing regulatory teams.
• Strong understanding of global clinical development and regulatory requirements.
• Ability to translate regulatory strategy into successful execution and delivery.
• Excellent stakeholder management and cross-functional leadership skills.