Regulatory Affairs Specialist - HCM

Regulatory Affairs Specialist will maintain in-depth knowledge of product regulatory areas, develop milestone plans for drug registrations, prepare high-quality regulatory submissions and manage registrations for new applications, license extensions and variations. The role includes developing packaging artwork to support new product launches and lifecycle management, providing regulatory status updates, advising on regulatory pathways, maintaining regulatory compliance databases, monitoring submission timelines, reviewing promotional materials for compliance, managing GMP site registrations, responding to DAV and hospital queries to support tenders, and coordinating regulatory matters with cross-functional teams to prevent stock shortages. Strong English, regulatory knowledge, and proactive, organized collaboration with internal and external stakeholders are required. The position is based in Vietnam (Ho Chi Minh City) and is suitable for candidates with a university degree in pharmacy and relevant regulatory affairs experience.