Senior Regulatory Affairs Professional APAC

About the role

The Senior Regulatory Affairs Professional is part of the Global Regulatory Affairs organization within the AP region. Working with local regulatory affairs departments, AP regional cross-functional teams, Global Regulatory Teams and other global functions, the role defines and implements the regional strategy for assigned products. It also supports regional affiliates with timely responses to Health Authority enquiries and general regulatory support for the pharmaceutical sector.

Key responsibilities

• Provide strategic regional regulatory input for assigned products across Asia-Pacific, supporting registrations, lifecycle management and ongoing compliance.
• Advise the Global Regulatory Team and Compound Development Team on regional requirements and guidelines, and act as a standing member where applicable.
• Help expedite new indications and line extensions, and guide local affiliates on faster submissions and approvals.
• Act as point of contact for local operating companies and support preparation for Health Authority meetings.
• Contribute to submission planning and timelines, including lifecycle submissions such as labeling changes, renewals and safety reports, and review critical documents.
• Take part in Rapid Response Teams and contribute to regional implementation of Core Data Sheets, reviewing labeling revisions and supporting labeling negotiations with HAs.
• Track submission and approval milestones and regional post-approval commitments, and provide AP evaluation in licensing activities.

Required profile

• Bachelor's degree or equivalent in Pharmacy, Life Sciences or a health-related discipline.
• 2 to 8 years of overall relevant pharmaceutical industry experience, preferably including regulatory experience.
• Excellent verbal and written English, including communication with senior management.
• Ability to manage multiple projects with strong organizational skills.

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).
• Understanding of drug development and marketed products, including AP pricing, reimbursement and supply chain impacts.
• Proficiency in Mandarin or other Asian languages.

Work operates independently with limited managerial oversight, requires flexible hours for early morning and evening meetings across time zones, and involves minimal regional business travel (1-2 times per year).