Regulatory Affairs Executive (Contract)
Core
Manage product lifecycle and regulatory compliance for Singapore and Malaysia, preparing and submitting registration dossiers to secure approvals and maintain licenses.
Role type
Regulatory Affairs Executive
Builds
Product registrations, renewals, variations, and compliance documentation for therapeutic products
Domain
Pharmaceutical / Life Sciences
Deliverable
client delivery
Required skills
Regulatory dossier preparation, lifecycle management, authority liaison, compliance monitoring, cross-functional collaboration
Preferred skills
Pharmacist registration, serving as designated Responsible Person (RP)
Technologies
HSA, NPRA regulatory systems
Responsibilities
Manage product lifecycle and regulatory compliance for Singapore and Malaysia; Prepare, review, and submit registration dossiers; Handle new registrations, renewals, variations, and post-approval commitments; Review product changes and assess regulatory impact; Oversee labelling, safety updates, and packaging compliance; Track submissions and respond to authority queries; Liaise with HSA, NPRA, and other authorities; Monitor regulatory changes and provide intelligence to stakeholders; Collaborate cross-functionally to support product launches and supply continuity.
