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 works with local regulatory affairs departments, AP Compound teams, Global Regulatory Teams and head office colleagues to define and implement the regional strategy for assigned oncology products. It reports to a supervisor and provides regional input into the global regulatory strategy, including the opportunity to place clinical trials in the region.

Key responsibilities

• Define and implement the regional strategy for assigned products and develop the regional regulatory strategy, considering changes in regulatory requirements and standards
• Advise the Global Regulatory Team and Compound Development Team on regional regulatory requirements, guidelines and processes, and keep up to date with the regional regulatory environment
• Provide early regional regulatory input to AP Compound teams to identify barriers and shape the global development plan, and guide local affiliates on accelerating submissions and approvals
• Manage interactions with local operating companies and regional functions, and act as point of contact for them
• Prepare for and take part in health authority meetings, and respond to health authority enquiries through the Rapid Response Teams
• Ensure product variations, including labeling changes, supplements, amendments and license renewals, are handled in the region
• Manage interactions with local/regional manufacturing sites, including export packaging components needed for product registration
• Track country regulatory changes, provide regulatory intelligence to regional management and head office, and follow up on post-approval commitments