Senior Regulatory Compliance Specialist in Maidenhead

Ready to shape global regulatory strategy for innovative oncology and biotechnology products while driving successful lifecycle management across international markets?Proclinical is seeking a Senior Regulatory Consultant to provide strategic and operational regulatory support for a portfolio of marketed and late-stage oncology and biotechnology products. This role involves both European and global regulatory responsibilities, focusing on lifecycle management activities and serving as a key member of cross-functional regulatory teams. You will play a pivotal role in developing and executing regulatory strategies while ensuring compliance with global and regional requirements. Responsibilities:Act as a member of EU and Global Regulatory Teams for assigned commercial programs.Develop and execute global regulatory strategies for post-approval products.Provide strategic regulatory guidance to cross-functional teams and stakeholders.Review and approve regulatory documents and submissions for global markets.Support regional regulatory teams, ensuring alignment with global objectives.Participate in Health Authority interaction planning and address regulatory queries.Represent Regulatory Affairs within multidisciplinary product teams.Contribute regulatory insights during quarterly safety review meetings and benefit-risk discussions.Identify regulatory risks, challenges, and opportunities, proposing actionable solutions.Lead EU lifecycle management activities, including variation submissions and regulatory procedures.Oversee labelling updates and implementation across European markets.Maintain Marketing Authorisations and ensure ongoing regulatory compliance.Manage regulatory aspects of clinical trial activities, including substantial amendments.Provide guidance on emerging EU regulatory requirements and their impact on product strategy.Extensive experience in Regulatory Affairs within the biotechnology or pharmaceutical industry.Proven expertise as a Global Regulatory Lead or in global regulatory strategy for innovative products.Strong knowledge of EU and global regulatory frameworks.Proficiency in European regulatory procedures, including variations, renewals, labelling updates, and PSURs.Ability to assess complex regulatory challenges and develop practical, strategic solutions.Experience reviewing and approving regulatory documentation for international markets.Familiarity with rare disease, specialty pharmaceutical, or biotech products.Exposure to both regional and global regulatory leadership responsibilities.By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -