Specialist, Regulatory Affairs
Core
Manage all aspects of regulatory submissions and post-marketing lifecycle management for pharmaceutical products in Malaysia to ensure compliance with local legislation.
Role type
Specialist Regulatory Affairs (Pharmaceuticals)
Builds
Regulatory compliance and supply continuity for new and established products
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Regulatory submission strategy, Marketing Authorization Applications, post-market lifecycle management, local regulatory compliance, audit support, CAPA management, drug shortage management
Preferred skills
Cross-functional collaboration, process improvement, risk mitigation
Technologies
Regulatory databases, submission portals
Responsibilities
Develop product registration plans and strategies; prepare and submit Marketing Authorization Applications and post-market dossiers; maintain regulatory data and documentation; ensure compliance with SOPs and manage CAPAs; support audits and inspections; develop local procedures; support drug shortage management
Seniority
Mid-level Specialist