
Regional Regulatory Affairs Lead
1 day ago
Coverage: Asia Region
Industry: Biologics / Specialty Pharmaceuticals
Our client is a leading multinational company in the biologics sector, committed to improving patients' lives through high-quality, innovative therapies. With a strong global footprint and a pipeline of specialty products, they are now seeking a Regional Regulatory Affairs Lead to join their growing team.
In this regional role, you will play a pivotal part in shaping regulatory strategies and ensuring successful product registrations across the Asia region. You'll act as the key link between global regulatory affairs, local partners, and health authorities - helping to bring life-changing products to market efficiently and compliantly.
Key Responsibilities:
Lead and support regulatory submissions across the Asia region, ensuring full compliance with local and country-specific requirements
Serve as the primary liaison between global regulatory affairs, in-country partners, and health authorities
Monitor regulatory changes in the region and provide timely updates to global teams
Collaborate closely with internal cross-functional teams including country managers, QA, and medical affairs
Support product lifecycle management and contribute to strategic regulatory planning
Maintain and update internal regulatory databases and systems
Facilitate effective communication and alignment with local agents and authorities
Travel Requirements:
Occasional travel to meet with health authorities, local regulatory partners, or attend key international regulatory events and conferences
What We're Looking For:
Advanced degree in life sciences, regulatory affairs, pharmacy, or a related field
Minimum 6 years of experience in regulatory affairs roles, with proven multi-market coverage in Asia
Strong knowledge of country-specific regulatory requirements for biologics or pharmaceuticals
Familiarity with electronic regulatory systems and databases
Excellent written and verbal communication skills in English
Strong project management capabilities and a collaborative, solution-oriented mindset
This is a high-impact role ideal for someone who thrives in a global matrix setting, is passionate about regulatory science, and wants to contribute to meaningful healthcare outcomes across diverse markets.
Please email your resume to Mervin Chai at for a confidential discussion.
EA License no: 16S8066 | Reg no.: R
Only successful candidates will be notified.
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