Disclaimer  Pre-Launch Test Posting Notice

The Regional Regulatory Affairs Manager / APAC Regulatory Lead is responsible for leading and executing regional regulatory strategies across the Asia-Pacific region to support product registrations, lifecycle management, market expansion, and ongoing regulatory compliance within the pharmaceutical, biotechnology, medical device, or healthcare industry. The role oversees regulatory activities across multiple APAC markets, ensuring that submissions, approvals, and post-marketing obligations are managed efficiently and in compliance with local regulatory requirements and global corporate standards. The candidate will act as the key regional regulatory representative, providing strategic guidance to cross-functional teams and senior management on regulatory risks, opportunities, timelines, and market access considerations across diverse healthcare jurisdictions.

The successful candidate will lead regional regulatory planning and coordinate complex submissions including new product registrations, variations, renewals, labeling updates, and regulatory agency interactions across APAC countries. Responsibilities include managing communications with regional health authorities, overseeing regulatory intelligence activities, supporting product launch strategies, ensuring compliance with evolving regulations, and driving harmonization initiatives across markets where possible. The role requires close collaboration with Global Regulatory Affairs, Quality Assurance, Clinical Operations, Medical Affairs, Pharmacovigilance, Supply Chain, Manufacturing, and Commercial teams to ensure alignment between business objectives and regulatory requirements. The ideal candidate should possess strong leadership, project management, and stakeholder engagement skills, with substantial experience managing multi-country regulatory activities within APAC and a strong understanding of regional healthcare regulations and submission processes.

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