Senior Regulatory Affairs Manager EU Oncology

4 weeks ago

England, United Kingdom Hays Full time

Senior Regional Regulatory Affairs Lead - Oncology (EU Markets) Your new company Are you a seasoned regulatory affairs professional with a passion for oncology and a deep understanding of European regulatory frameworks? Our client, a leading global biopharmaceutical company, is seeking a Senior Regional Regulatory Affairs Lead to drive regulatory strategy and execution across the EU region for one or more oncology products. Your new role As a key member of the Global Regulatory Team, you will be instrumental in shaping and delivering regional regulatory strategies that support clinical development and market access for innovative oncology therapies. You'll lead regulatory submissions, manage agency interactions, and ensure compliance across the product lifecycle-from investigational trials to post-marketing commitments.Key Responsibilities: Develop and implement EU-focused regulatory strategies aligned with global objectives. Lead regulatory submissions for clinical trials and marketing authorisations across European markets. Act as the primary contact for EU health authorities, managing interactions and negotiations to secure optimal product labelling and approvals. Provide strategic input to cross-functional teams on regulatory pathways including accelerated approvals, orphan drug designation, and paediatric plans. Collaborate with the Labelling Working Group to define and negotiate regional product labels. Monitor and interpret EU regulatory developments, ensuring proactive compliance and strategic adaptation. What you'll need to succeed Proven experience in EU regulatory affairs within the pharmaceutical or biotech industry. Strong knowledge of European regulatory procedures for CTAs, MAs, post-approval changes, and renewals. Expertise in oncology drug development and regulatory strategy. Excellent communication and stakeholder management skills. Ability to lead complex regulatory projects and mentor junior team members. What you'll get in return Remote working 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.

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