Regulatory Affairs, QA & PV Specialist - Pharmaceuticals

This position serves as the primary point of contact for all regulatory affairs, quality assurance, and pharmacovigilance activities in Hong Kong, ensuring alignment with local Department of Health regulations and international standards. The role involves developing regulatory strategies, managing submissions, maintaining product registrations, and ensuring compliance with labelling and promotional requirements while also overseeing licensing activities including import permits and antibiotics-related authorizations. On the quality side, the position supports GMP and GDP compliance, batch release, audits, and coordination with manufacturing and distribution partners, while also handling product quality issues and regulatory reporting. From a pharmacovigilance perspective, the role focuses on maintaining a compliant PV system, handling safety reporting, conducting training, and supporting audits. The position requires close collaboration with regional and global stakeholders, including commercial, medical, and external partners, while also developing SOPs, managing documentation systems, and contributing to continuous improvement initiatives across RA, QA, and PV functions.