Regulatory Affairs Manager Oncology CTA

An exciting opportunity has arisen for an experienced Regulatory Affairs Manager to support innovative oncology and advanced therapy programmes within a global biopharmaceutical environment.This role will play a key part in driving regulatory strategy, leading Clinical Trial Applications (CTA), EU CTR submissions, substantial amendments, and broader regulatory activities across EU. Working closely with global and regional stakeholders, you will support the development of cutting-edge therapies in a fast-paced, highly collaborative setting.Key ResponsibilitiesLead regulatory affairs activities for development-stage and marketed products.Drive CTA submissions, amendments and EU CTR activities across Europe.Develop and execute regulatory strategy in partnership with global regulatory teams.Prepare and coordinate regulatory submissions in line with EU and ICH requirements.Represent Regulatory Affairs within cross-functional project teams.Monitor evolving European regulatory requirements and provide strategic guidance to stakeholders.Experience RequiredProven experience within Regulatory Affairs in the pharmaceutical or biotech sector.Strong knowledge of Clinical Trial Applications (CTA) and the EU Clinical Trials Regulation (EU CTR).Experience developing and executing regulatory strategy for clinical development programmes.Broad understanding of European regulatory requirements and procedures.Experience supporting interactions with health authorities and cross-functional ..... full job details .....