Regulatory Affairs Manager

Regulatory Affairs Manager

We are seeking an experienced Regulatory Affairs Manager to lead the development and execution of regulatory strategies for our portfolio across therapeutic areas. This role is based on-site at our London office and reports to the Head of Regulatory Affairs.

Key Responsibilities

• Develop and implement global regulatory strategies to secure and maintain marketing authorisations
• Lead preparation and submission of regulatory dossiers (CTD, variations, renewals) to MHRA, EMA and other agencies
• Provide strategic regulatory input to development teams and ensure alignment with evolving regulations
• Monitor and interpret regulatory intelligence to guide decision-making and risk mitigation
• Collaborate with cross-functional teams including clinical, safety, quality and commercial
• Manage interactions with health authorities including formal meetings and responses to queries

Qualific...