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 & 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 & GovernanceEnsure compliance with EU and global regulatory requirements and maintain inspection readinessStay up-to-date with evolving regulatory frameworks, advising the business on impact and opportunityOversee and maintain accuracy of regulatory systems and documentationSupport audits and ensure SOP adherence and continuous process improvement

What you'll need to succeedProven experience in EMEA Regulatory Affairs, ideally within lifecycle managementStrong knowledge of EU regulatory procedures (MRP/DCP, variations, PSUSA/aggregate reports)Demonstrated ability to develop and execute regulatory strategy across complex submissionsMust have strong working knowledge of worksharing and super groupingExperience in line management or mentoring junior team membersExcellent stakeholder engagement and cross-functional collaboration skills

What you'll get in return Flexible working options available. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.