Regulatory Affairs Expert with Global Compliance
4 days ago
Apsida Life Science is seeking a Regulatory Affairs Specialist for a long-term project in the Asia-Pacific region. The ideal candidate will have expertise in regulatory requirements for Vietnam, Philippines, Thailand, Malaysia, Singapore, and other ROW countries.
The role involves providing strategic guidance on regulatory compliance, collaborating with internal teams to ensure product registrations and submissions meet global standards. You will oversee GMP registrations, compile submission packages, and engage closely with cross-functional teams to provide integrated regulatory support.
Key responsibilities include:
- Verifying strategic approaches and timelines to align zone strategies with Affiliate Regulatory Affairs teams
- Applying knowledge of regional regulatory requirements to inform business decisions
- Managing MAT-related issues, including escalations with Local and Global Regulatory Affairs, and external partners
- Facilitating translation requests, artwork finalization, and certificate management for submissions
The successful candidate will be based in the Asia-Pacific region and will work collaboratively with the Marketing, Trade Marketing, Innovation, Industrial Affairs, Medical, Supply Chain, Pharmacovigilance, and Quality teams.
The estimated salary for this position is $80,000 - $110,000 per year, depending on experience and qualifications.
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