Regulatory Affairs Executive
Core
Manage the life cycle of existing product portfolios and prepare registration dossiers to obtain regulatory approvals in Singapore and Malaysia.
Role type
Regulatory Affairs Executive (Contract)
Builds
Product registrations, renewals, variations, and compliance documentation for pharmaceutical products.
Domain
Pharmaceutical industry, Regulatory Affairs, Quality Management (GDP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, product lifecycle management, health authority liaison, regulatory intelligence, quality compliance oversight, cross-functional collaboration, documentation maintenance, process improvement
Preferred skills
Registered pharmacist status, GDP self-inspection experience, multi-product type knowledge (chemical drugs, biologics, drug-device combinations), Malaysia regulatory experience
Technologies
Health authority submission systems, regulatory databases, quality management systems
Responsibilities
Manage product registration lifecycle and submit dossiers to health authorities; oversee Good Distribution Practice activities including recalls and inspections; liaise with Singapore and Malaysia health agencies; guide junior team members on regulatory procedures; support audits and inspections; review promotional materials for compliance.
Seniority
Mid-level, hands-on IC
