Leads medical affairs for a neurovascular MedTech portfolio, with responsibility for medical governance, clinical-study safety review, evidence generation, scientific communication, and stakeholder support.
About this role
Part of Global Regulatory Affairs, the Manager, APAC, Regulatory Affairs, Oncology works with AP regulatory departments, product teams and global colleagues. The role sets regional strategy for assigned oncology products, advising on country requirements affecting development, registration and lifecycle plans, and tracks regulatory changes for regional and global teams. Work includes planning submissions; reviewing dossier documents; coordinating clinical-trial, registration and post-approval filings such as labeling changes, renewals and safety reports; tracking milestones and commitments; preparing for Health Authority meetings; and contributing to agency responses. It also involves coordination with local affiliates, manufacturing sites and regional partners. Applicants need a bachelor's degree or equivalent in pharmacy, life science or a health-related discipline, plus 8+ years overall including 5+ years in pharmaceutical regulatory work, or a master's/PharmD with 6+ years, or a PhD with 4+ years. Hands-on AP product-registration experience and experience preparing Health Authority submission documents are required.
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