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 is accountable for leading and giving regulatory strategic input, and operates under the supervision and support of a supervisor.

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
• Ensure product variations, including labeling changes, supplements, amendments and license renewals, are handled in the region, and give regional affiliates timely responses to Health Authority enquiries
• Manage interactions with local operating companies, regional functions and manufacturing sites, and prepare for and present to Health Authorities when needed
• Support submission planning, review critical documents, coordinate post-approval submissions and follow up on approval milestones
• Keep regional management and head office informed of changes in country regulatory requirements and provide regulatory intelligence