The EU Regulatory Affairs Manager supports one or more products from an EU regulatory perspective and helps ensure that all required EU licenses are obtained and maintained for clinical trials and marketed medicinal products.Responsibilities may include acting as EU Regulatory Lead for assigned products; planning and managing regulatory submissions such as clinical trial and marketing applications; implementing regulatory strategies, processes and activity plans in line with EU legislation and global filing plans; providing guidance on EU regulatory mechanisms supporting product development, including scientific advice, orphan drug applications, paediatric plans and approval pathways; supporting EU label negotiations; contributing to regional regulatory product strategies; and identifying regulatory risks and expectations.The role also involves monitoring new legislation, regulations and guidance relevant to company products; conducting regulatory research to identify precedents and support product advancement; and evaluating and communicating the impact of regulatory developments and competitor labelling.Requirements include a university degree, previous experience in a similar regulatory affairs role, hands-on experience with EU registration procedures across product development and post-marketing phases, knowledge of EU medicinal product legislation, experience working with policies, procedures and SOPs, strong written and verbal communication skills, problem-solving and conflict resolution abilities, and basic proficiency in AI tools.