Director, APAC Regulatory Affairs, Hematology

About the role

Johnson & Johnson is hiring a Director, APAC Regulatory Affairs, Hematology, a People Leader in the Regulatory Affairs group. The role sits in the AP region and 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. It is responsible for leading regulatory strategy for the region, supporting global regulatory strategy, and managing interactions with health authorities and manufacturing sites.

Key responsibilities

• Define and implement the regional regulatory strategy for assigned therapeutic areas and products, including registration schedules, lifecycle submissions and post-registration activities such as labeling changes and license renewals
• Consolidate strategy and prioritize AP countries (Japan, China, North Asia, Australia/New Zealand, India/Southeast Asia) aligned with business and R&D objectives
• Advise the Global Regulatory Team and Compound Development Team on regional regulatory requirements, guidelines and processes, and give early regulatory input to 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
• Provide regional regulatory support to affiliates, including generics and biosimilars, and keep regional management and head office informed of regulatory changes
• Lead and coach regulatory staff, manage budgets, performance and compliance, and implement workforce and succession plans
• Support the VP, Regulatory Affairs AP with regional metrics and help shape a favorable regulatory environment

Required profile

• Deep 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
• 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

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
• Competitor intelligence and awareness of pricing and reimbursement issues in the AP region