Senior Regulatory Affairs Associate – Safety Labelling

• Plan, coordinate, and deliver global and regional safety labelling activities and regulatory submissions throughout the product lifecycle
• Execute safety labelling regulatory activities while maintaining compliance with client procedures, regulatory requirements, and internal systems and processes
• Assess emerging safety information, regulatory commitments, and pharmacovigilance outputs to determine labelling impact, submission requirements, implementation timelines, and regulatory risks
• Author, review, and maintain regulatory documentation, including Module 1 content, and prepare submission-ready dossiers with subject matter experts and stakeholders
• Manage end-to-end safety labelling submissions, including planning, dossier compilation, submission package preparation, RIMS maintenance, health authority query responses, and post-approval implementation
• Serve as the primary Global Regulatory Affairs contact for assigned safety labelling activities
• Maintain and oversee global and regional product information, including EU Product Information
• Coordinate linguistic review, translation, readability testing, and implementation activities for safety labelling updates
• Support development, maintenance, and implementation of CCDS, CCSI, and associated local labelling documentation
• Provide regulatory support for safety-related updates arising from PSURs, signal evaluations, risk management activities, and other pharmacovigilance initiatives
• Support change control processes and ensure approved changes are implemented within required regulatory timelines
• Coordinate with publishing, operations, and affiliate teams on regulatory dossier assembly, validation, submission, and implementation
• Liaise with health authorities, affiliates, and stakeholders on safety labelling matters and regulatory questions
• Monitor and communicate changes to global regulatory requirements, guidance, and labelling standards
• Develop and maintain submission plans, trackers, metrics, and regulatory records for inspection readiness and compliance monitoring
• Contribute to cross-functional regulatory and safety governance teams

• University degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related scientific discipline
• Working knowledge of global and regional regulatory requirements for medicinal product safety labelling and lifecycle management, including EU labelling requirements
• Understanding of CCDS, CCSI, and their implementation into product information and artwork
• Knowledge of safety signal management and the impact of confirmed safety signals on product labelling
• Understanding of regulatory submission processes, including Module 1 documentation, lifecycle management activities, and health authority interactions
• Familiarity with Regulatory Information Management Systems (RIMS) and electronic document management systems
• Strong planning, organizational, and time management skills, with the ability to manage multiple priorities and deadlines
• Strong analytical and problem-solving skills, with the ability to interpret regulatory requirements and propose practical solutions
• Excellent communication, stakeholder management, and interpersonal skills, with the ability to collaborate effectively across cross-functional teams
• Fluent in English, both written and spoken

• Flexibility in working location across various European locations
• Home-based or office-based working