Director, APAC Regulatory Affairs, Hematology

About the role

The Regional Regulatory Leader Asia Pacific (AP) is a member of 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, and leads regulatory strategy for assigned therapeutic areas. It is a leadership role reporting to the VP, Regulatory Affairs AP, in a matrix environment.

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, and advise the Global Regulatory Team and Compound Development Team on regional requirements.
• 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 Steering Committees, and expedite commercialization of new products and indications.
• Develop the regional registration schedule, advise on dossier content and timelines, coordinate post-approval submissions and follow up on approval milestones.
• Provide regulatory intelligence on country requirement changes and support regional implementation of strategies such as generics and biosimilars.
• Manage and coach regulatory staff, including in local offices, and support talent development and succession planning.

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 regulatory developments and communicate AP regulatory strategy to global teams.
• Understanding of Health Authority structures, dossier requirements, labeling rules and the competitive landscape.
• Leadership competencies: live the company's Credo, connect externally, shape strategy and grow talent.