Senior Regulatory Specialist

We are seeking an experienced Regulatory Affairs Manager to lead regulatory activities across our UK affiliate. This is an exciting opportunity to play a pivotal role in ensuring regulatory compliance, driving regulatory strategy, and supporting the lifecycle management of a diverse pharmaceutical portfolio.

Working closely with UK, European and Global stakeholders, you will provide expert regulatory leadership, manage a high-performing Regulatory Affairs team, and represent the organisation in interactions with the MHRA and other regulatory authorities.

• sLead UK regulatory activities for marketed products, including regulatory strategy, submissions, approvals and lifecycle management
• .Manage preparation, review and submission of regulatory documentation, including CTD dossiers and post-authorisation activities
• .Lead regulatory projects including new registrations, variations, renewals, Scientific Advice meetings, PIPs and Orphan Drug Designations
• .Provide regulatory input into product development strategies and support EU/UK regulatory planning
• .Represent Regulatory Affairs in cross-functional teams and provide expert advice on regulatory requirements and risks
• .Manage interactions with the MHRA, including responses to regulatory questions and meetings
• .Ensure regulatory databases, trackers, SOPs and controlled documents are maintained and compliant
• .Support labelling activities, including SmPCs, PILs and product information updates
• .Drive continuous improvement of regulatory processes and support audit readiness

• ls Degree in Life Sciences or a related scientific disciplin
• e.Approximately 7 years’ experience in Regulatory Affairs within the pharmaceutical industr
• y.Experience with CTD documentation, MAAs, national and centralised procedure
• s.Strong understanding of post-marketing activiti
• es Experience interacting with the MHRA and managing regulatory authority response
• s.Knowledge of SmPCs, PILs, labelling requirements and regulatory compliance processe
• s.Strong project management, organisational and stakeholder management skill
• s.Ability to influence cross-functional teams and work effectively in a global environmen
• t.Experience writing SOPs, improving processes and maintaining regulatory complianc