Senior Regulatory Affairs Professional APAC

About the role

Johnson & Johnson's Senior Regulatory Affairs Professional is part of the Global Regulatory Affairs organization, based in the AP region and located in Chiyoda, Tokyo. The role works with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products, and supports regional affiliates with timely responses to Health Authority enquiries.

Key responsibilities

• Advise the Global Regulatory Team and Compound Development Team on regional regulatory requirements, guidelines and issues affecting product strategy, and act as a standing GRT member where applicable.
• Provide regional input to speed up new indications and line extensions, and guide local affiliates on accelerating submissions and approvals.
• Act as point of contact for local operating companies and support preparation for Health Authority interactions, including timing and strategy for HA meetings.
• Contribute to submission planning and timelines, including lifecycle submissions such as labeling changes, renewals and safety reports, and review critical submission documents.
• Take part in Rapid Response Teams to respond quickly to Health Authority questions.
• Support the regional implementation of Core Data Sheets, review labeling revisions and support labeling negotiations with HAs.
• Track submission and approval milestones and regional post-approval commitments, ensuring follow-up and ongoing compliance.
• Evaluate licensing activities in the AP region, monitor regional regulatory changes and update global teams on their impact.

Required profile

• Bachelor's degree or equivalent in Pharmacy, Life Sciences or another health-related discipline.
• 2 to 8 years of overall relevant pharmaceutical industry experience, preferably including regulatory experience.
• Excellent verbal and written English, including the ability to communicate with senior management.
• Ability to operate independently with limited managerial oversight and to set longer-term priorities in consultation with the supervisor.

Preferred qualifications

• Hands-on experience registering pharmaceutical products in AP countries and familiarity with AP regulatory systems.
• Experience preparing Health Authority submission documents (CMC and/or registration dossiers) and in HA interactions.
• Understanding of drug development and marketed products, including AP pricing, reimbursement and supply chain impacts on registration.
• Ability to manage multiple projects, proficiency in Mandarin or other Asian languages, and cultural sensitivity in a multicultural, matrix environment.