Director, APAC Regulatory Affairs, Hematology

About the role

The Regional Regulatory Leader Asia Pacific (AP) is a People Leader in the Global Regulatory Affairs organization, based in the AP region. The position works with local regulatory affairs departments, AP Integrated Value Teams, AP Therapeutic Area Steering Committees and head office teams to define and implement the regional strategy for assigned products, including hematology. It is accountable for regional regulatory strategy, strategic input into global regulatory strategy, and for supporting regional affiliates with regulatory matters.

Key responsibilities

• Define and implement the regional regulatory strategy for assigned products and therapeutic areas, including Japan, China, North Asia, Australia/New Zealand and India/Southeast Asia
• Advise the Global Regulatory Team and Compound Development Team on regional regulatory requirements, guidelines and processes, and on country-specific regulatory issues affecting product strategy
• Support the commercialization of new products, indications and line extensions through early regional regulatory input in Integrated Value Teams and Therapeutic Area SLTs
• Manage interactions with local operating companies, health authorities and regional functions, including preparing for and presenting to health authorities
• Lead regulatory submissions: register schedules, dossier content, lifecycle submissions (labeling changes, renewals, safety reports), and rapid response to health authority questions
• Ensure product variations such as labeling changes, supplements, amendments and license renewals are handled in the region
• Oversee regulatory staff, provide coaching and feedback, and manage budgets, performance and compliance
• Help develop department processes and support the VP, Regulatory Affairs AP with regional metrics

Required profile

• Detailed knowledge of local laws, regulations and guidelines in the region covering the full drug life cycle
• Experience in drug development and/or marketed products, and good understanding of the pharmaceutical industry
• Ability to anticipate and influence regulatory developments and to communicate AP regulatory strategy to global teams
• Understanding of HA structures, submission dossiers, labeling requirements and resource planning
• Leadership competencies: Live Our Credo, Connect, Shape and Grow, with independence in a complex environment