Regulatory Affairs Executive - JL
Core
Manage the life cycle of the pharmaceutical product portfolio and ensure regulatory compliance for Singapore and Malaysia markets.
Role type
Regulatory Affairs Executive (Responsible Person)
Builds
Product registrations, renewals, variations, and compliance dossiers for therapeutic products.
Domain
Pharmaceutical industry, Singapore and Malaysia markets.
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission preparation, post-approval commitments management, labelling and packaging compliance, health authority liaison, regulatory intelligence, quality management oversight, Good Distribution Practice (GDP) compliance.
Preferred skills
Registered pharmacist status, experience with National Pharmaceutical Regulatory Agency, knowledge of chemical drugs/biologics/drug-device combinations, audit support.
Technologies
Health authority submission systems, regulatory databases, submission trackers.
Responsibilities
Prepare and submit registration dossiers, manage product life cycle activities (variations, renewals), liaise with health authorities, oversee GDP operational quality activities, support health authority inspections, guide junior team members.
Seniority
Mid-level, hands-on IC
