12-Month Contract | Hybrid Working | Potential to Convert Permanent
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.
This opportunity is ideally suited to a regulatory leader who combines strong submission expertise with people leadership and a hands-on approach to regulatory execution.
TPBN1_UKTJ
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