The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration, tracking and lifecycle maintenance
Job Summary
The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration, tracking and lifecycle maintenance.
This position ensures that product registrations across APAC countries are progressing according to timelines and supports regulatory compliance throughout the region.
The role leads and executes various region-level projects including biosimilar registration plans, label sanity checks, and competitor monitoring.
Matching Summary
The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration, tracking and lifecycle maintenance.
Skills & Requirements
Must-have
Product registration and submissions
Regulatory compliance management
Cross-functional teamwork
Affiliate coordination
Regulatory strategy execution
Project management
Regulatory operations coordination
Nice-to-have
Strong communication skills
Effective negotiation skills
Problem solving and issue analysis
Total Quality Management (TQM) skills
Budget management
Key Requirements
Bachelor’s Degree in Pharmacy, Life Science or Science
5-7 years regulatory affairs experience
Experience with pharmaceutical regulatory environment
Experience interfacing with government and regulatory agencies