Senior Regulatory Affairs Consultant – EU Regulatory Strategy, MAA

• Lead and manage Marketing Authorisation Applications (MAAs) with strategic regulatory input on application pathways and dossier packages
• Develop and execute regulatory strategies aligned with product development timelines and commercial objectives
• Conduct critical document reviews and provide competitive regulatory intelligence to support informed decision-making
• Prepare core regulatory documents including briefing books, paediatric development plans, and scientific advice packages
• Own Module 1 submission documentation and coordinate submission preparation activities
• Manage responses to health authority questions and requests with timely, high-quality deliverables
• Ensure timely execution of regulatory activities across assigned products and programmes
• Lead pre-submission activities, scientific advice procedures, and post-approval regulatory maintenance with the European Medicines Agency (EMA)
• Serve as key interface with health authorities and cross-functional stakeholders including Clinical, Medical, Safety, Quality, CMC, and Commercial functions
• Influence senior stakeholders and navigate complex regulatory challenges in a consultancy environment

• University degree in a Life Science discipline
• Significant Regulatory Affairs experience supporting EU product development and lifecycle management
• Proven experience leading or supporting EMA interactions and regulatory procedures
• Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements
• Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials
• Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement
• Excellent project leadership, stakeholder management, and communication skills
• Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment
• Fluent in English, written and spoken