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
• Ensure product variations such as 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
• Lead regulatory activities on AP Integrated Value Teams and AP Therapeutic Area SLT, and expedite commercialization of new products and indications
• Develop the regional registration schedule, advise on dossier content and submission timelines, and coordinate post-approval submissions and compliance
• Provide regional regulatory input to licensing activities and evaluate licensing proposals
• Manage and coach regulatory staff, including in local offices, and support talent development and succession planning

Required profile

• Deep knowledge of local laws, regulations and guidelines covering the full drug life cycle, and of the pharmaceutical industry
• Experience in drug development and/or marketed products, and good understanding of the therapeutic area and its scientific and medical principles
• Detailed knowledge of Health Authority structures and how to engage them effectively
• Ability to lead managers and senior contributors in a matrix environment, with independence in decision-making on regional strategy

Required skills

• Regulatory strategy and submissions, including dossier components and timelines
• Labeling requirements and labeling negotiations with Health Authorities
• Resource planning, mentoring and line management