Regulatory affairs Manager post approval MRP DCP

Your new companyAre you an experienced Regulatory Affairs professional looking to take ownership of life cycle strategy across a dynamic EU portfolio? We''re partnering with a leading healthcare organisation to find a Regulatory Affairs Consultant, life cycle management, to join their growing team.This is a fantastic opportunity to play a key strategic and operational role across product life cycle 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 roleKey Responsibilities Life cycle Management and SubmissionsLead end-to-end life cycle management activities including variations, renewals, labelling updates, and aggregate reports.Prepare 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 ..... full job details .....