Regulatory Affairs Manager OTC

Your new company Are you an experienced Regulatory Affairs professional looking to take ownership of lifecycle strategy across a dynamic EMEA portfolio? We''re partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant - LCM to join their growing team.This is a fantastic opportunity to play a key strategic and operational role across product lifecycle management, working at the intersection of CMC, regulatory strategy, and cross-functional collaboration. You''ll contribute to both innovation and maintenance of existing products while managing a small team.Your new role Key ResponsibilitiesLifecycle Management and SubmissionsLead end-to-end lifecycle management activities including variations, renewals, labelling updates, and aggregate reportsPrepare and submit variation applications via EU procedures (MRP/DCP, Workshare), including complex submissions and super-groupings.Develop submission strategies, including reference member state selection and regulatory pathwaysSupport marketing authorisation applications for early-stage innovation projectsRegulatory StrategyProvide strategic regulatory input and technical CMC guidance to cross-functional stakeholdersPartner with product development teams to define regulatory requirements, risks, and timelinesContribute to the design and execution of development programmes across the EMEA regionCompliance and GovernanceEnsure compliance with EU and global regulatory requirements and maintain inspection ..... full job details .....