Regulatory Affairs Senior Manager EU

Your new company An exciting opportunity has arisen for an experienced EU Regulatory Affairs Senior Manager to join a leading global biopharmaceutical organisation. This is a pivotal role where you''ll shape and execute EU regulatory strategy across both clinical development and life cycle management, working at the heart of innovative product pipelines.Your new role As a key member of the regulatory team, you will partner with cross-functional stakeholders to drive successful submissions and ensure compliance across EU markets. You''ll play a strategic and hands-on role, influencing programmes from early development through to post-approval lifecycle activities.Key ResponsibilitiesLead the planning, coordination and preparation of EU regulatory submissions, supporting EU Regulatory LeadsContribute to the development and execution of EU regulatory strategies aligned to business objectivesIdentify and assess regulatory risks, proposing effective mitigation strategiesRepresent Regulatory Affairs on cross-functional project teams and governance forumsDrive alignment across regulatory functions and stakeholdersProvide expert regulatory guidance throughout RandD and product lifecycleEngage with Health Authorities, partners and external stakeholders representing the organisationBuild and maintain strong relationships with regulatory agencies and collaboratorsSupport and lead health authority meetings, inspections and auditsMonitor the evolving EU regulatory landscape and assess ..... full job details .....