(Senior) Manager, Regulatory Affairs

(Senior) Manager, Regulatory Affairs (Consultant)Location: Maidenhead/Remote (hybrid)Duration: 12 months initial (FOUR days per week / 0.8 FTE)Rate: £70-85 per hour (based on experience)We are working with a leading pharmaceutical company who are seeking an experienced Senior Manager, Regulatory Affairs to shape and drive regulatory strategy across the Europe Area. This high-impact role will work across development and marketed products, partnering closely with global teams, affiliates and health authorities to ensure successful regulatory outcomes.Key ResponsibilitiesLead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe AreaRepresent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategyCollaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activitiesAssess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvalsMonitor evolving European legislation and lead the development of regulatory responses and policy implementationSkills and Experience RequiredDegree in pharmacy, biology, chemistry, pharmacology, or related life sciences disciplineStrong experience in European Regulatory Affairs, including centralised, MRP/DCP and national proceduresProven track record leading regulatory activities for ..... full job details .....