The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products within the oncology therapeutic area
Job Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products within the oncology therapeutic area.
This role involves leading regulatory strategic input, ensuring product variations and labeling changes are effected, and providing timely responses to Health Authority inquiries.
The position requires managing interactions with local/regional manufacturing sites and keeping track of changes in country regulatory requirements to provide regulatory intelligence.
Matching Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products within the oncology therapeutic area.
Skills & Requirements
Must-have
Regional regulatory strategy implementation
Health Authority interactions
Product registration and lifecycle management
Oncology therapeutic area expertise
Regulatory intelligence gathering
Nice-to-have
Cultural sensitivity and adaptability
Proactive team player
Achievement-oriented with flexibility
Key Requirements
Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
8+ years of overall experience (5+ years relevant pharmaceutical industry and regulatory experience)
Hands-on experience in pharmaceutical product registration in AP countries
Familiarity with AP regulatory systems and product registration requirements
Previous experience in preparing documents for health authority submissions