Regulatory Lead, Marketed products

vor 3 Wochen

Germany Discover International Vollzeit

The Global Regulatory Affairs Lead (Oncology – Marketed Products) is responsible for developing and executing global regulatory strategies to support the lifecycle management of marketed oncology products. This role provides strategic and operational regulatory leadership across multiple regions, ensuring continued compliance, label optimization, and product maintenance in alignment with business objectives and evolving regulatory requirements.The successful candidate will serve as the primary global regulatory point of contact for assigned oncology products, partnering cross-functionally with regional affiliates, clinical development, safety, medical affairs, and commercial teams to ensure that regulatory deliverables are met and that patient access is maintained worldwide.Key ResponsibilitiesStrategic LeadershipLead global regulatory strategies for marketed oncology products, including variations, line extensions, labeling updates, and post-approval commitments.Provide strategic input into lifecycle planning, including risk assessments and regulatory intelligence for oncology indications.Serve as the global regulatory representative on cross-functional product teams, driving regulatory excellence and proactive compliance.Compliance and IntelligenceMonitor and interpret global oncology regulatory trends, guidelines, and legislation impacting marketed products.Ensure ongoing compliance with global regulatory requirements and internal SOPs.Drive continuous improvement in regulatory processes, systems, and cross-functional collaboration.Stakeholder ManagementBuild and maintain strong partnerships with internal stakeholders (e.g., Quality, CMC, Medical Affairs, Commercial) and external partners (e.g., regulatory consultants, alliance partners).Provide expert regulatory advice to senior management on potential impacts of regulatory changes and opportunities for optimization.Qualifications and ExperienceEducation:Advanced degree in life sciences, pharmacy, or a related discipline (PhD, PharmD, or MSc preferred).Experience:Minimum 8–10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, PMDA, Health Canada, etc.) and oncology drug development lifecycle.Proven track record of successful regulatory submissions and interactions with major Health Authorities.Skills and Competencies:Strategic thinker with ability to balance scientific, technical, and business perspectives.Excellent leadership, communication, and negotiation skills.Ability to manage multiple complex projects across geographies and time zones.Strong analytical, organizational, and problem-solving abilities.High level of integrity, accountability, and cross-functional collaboration.

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