Pharmaceutical product registration in ap countries
Familiarity with ap regulatory systems
Health authority interactions
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, including leading regulatory strategic input and identifying regional requirements for successful regulatory filings
Job Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, including leading regulatory strategic input and identifying regional requirements for successful regulatory filings.
This role ensures product variations, labeling changes, and renewals are effected in the region, and provides timely responses to Health Authority inquiries and general regulatory support to affiliates.
The position requires managing interactions with local/regional manufacturing sites and regulatory policy professionals to track changes in country regulatory requirements and provide regulatory intelligence.
Matching Summary
The Regional Regulatory Manager Asia Pacific is responsible for defining and implementing the regional strategy for assigned products, including leading regulatory strategic input and identifying regional requirements for successful regulatory filings.
Skills & Requirements
Must-have
pharmaceutical product registration in AP countries
familiarity with AP regulatory systems
Health Authority interactions
regulatory strategy development
product lifecycle management
Nice-to-have
cultural sensitivity
proactive team player
achievement-oriented
flexibility and adaptability
Key Requirements
Minimum of bachelor’s degree or equivalent
8+ years of overall experience
5+ years relevant pharmaceutical industry and regulatory experience
Hands-on experience in pharmaceutical product registration in AP countries