Manager, APAC Regulatory Affairs, Oncology

About the role

The Manager, APAC Regulatory Affairs, Oncology is part of the Global Regulatory Affairs organization and sits in the AP region. The role defines and implements the regional strategy for assigned oncology products, working with local regulatory affairs departments, AP Compound teams, Global Regulatory Teams and head office colleagues. It is accountable for giving regulatory strategic input, supporting regional and country input into the global regulatory strategy, and ensuring product variations such as labeling changes, supplements, amendments and license renewals are handled in the region.

Key responsibilities

• Define and implement regional and local regulatory strategy for assigned products, in line with multinational/regional strategies that cover development, registration and lifecycle management
• Advise the Global Regulatory Team and Compound Development Team on regional requirements, guidelines and processes, and give early regulatory input to compound teams to shape the global development plan
• Manage interactions with local operating companies and health authorities, including preparing for and attending health authority meetings and responding to health authority enquiries
• Support submissions: input to submission planning and timelines, generic content plans, critical documents, and rapid response to health authority questions
• Provide regional advice on labeling changes, supplements, amendments, license renewals and Core Data Sheets, and review labeling development and revisions
• Manage interactions with regional manufacturing sites, including export packaging components, and keep regional management informed of changes in country regulatory requirements
• Help prepare the regional regulatory office's processes and procedures, and support the Head of Regulatory Affairs AP with regional metrics

Required profile

• Bachelor's degree or equivalent in pharmacy, life sciences or a health-related discipline
• 8+ years of overall experience, including 5+ years in pharmaceutical industry and regulatory affairs; or Master's/PharmD with 6+ years, or PhD with 4+ years
• Hands-on experience in pharmaceutical product registration in AP countries, preferably in oncology
• Experience preparing documents for health authority submissions (CTA, CMC documents, registration dossiers)
• Ability to handle multiple projects, strong organizational skills, and ability to communicate to senior management
• Working knowledge of regional regulations and experience interacting with health authorities
• Some regional business travel (10-15%) and occasional international travel (3-5 times per year); flexible hours across time zones

Required skills

• Proficiency in written and spoken English; Mandarin or Asian languages preferred
• Excellent verbal and written communication skills
• Microsoft Office and internet resources
• Understanding of the pharmaceutical industry, drug development, and the full drug lifecycle