Regulatory Affairs Manager Uk and Ire

Your new company This leading global biopharmaceutical company is looking for an experienced Regulatory Affairs Manager to join their UK Affiliate Regulatory team on a maternity cover basis. This is a high-impact role working on established products approved via the EMA Centralised Procedure, with strong exposure to post-approval lifecycle activities.Your new role Reporting to the Head of UK Regulatory, you will take ownership of one or more products of medium complexity and strategic impact, working closely with UK, Ireland, and EU regulatory stakeholders.Key ResponsibilitiesLead post-MAA lifecycle management activities for assigned productsManage complex Type II variations and other regulatory proceduresSupport and maintain Paediatric Investigation Plans (PIPs)Contribute to clinical trial regulatory activities as requiredPlan and execute local regulatory submissions in line with EMA, MHRA, and corporate standards.Provide local regulatory input into global regulatory strategiesEnsure product compliance, including IMR, PMCs, and agency commitmentsDevelop and maintain local product labels in line with legislation and internal standardsReview promotional and non-promotional materials (where in scope)Act as the primary point of contact with regulatory authoritiesSupport alignment between local regulatory requirements and global processesWhat you''ll need to succeed Proven experience in UK/EU Regulatory Affairs within pharma or biotechStrong background in post-approval ..... full job details .....