I
IE DIRECT SDN BHD
Regulatory Affairs Executive
Skills
Testing & QABusiness DevelopmentInternal Audit
2 months ago
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Important information
Contract type:
Permanent
Salary:
MYR 36,000 – MYR 48,000 / year
Location:
Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia
Work mode:
Onsite
Published on:
11 August 2026
What they need
- Prepare, compile, review, and submit product registration dossiers for pharmaceuticals, health supplements, and natural products to NPRA.
- Manage new product registrations, variation applications, renewals, notifications, and maintenance of registered products.
- Liaise with NPRA and other regulatory authorities regarding product registration, regulatory queries, and submission requirements.
- Coordinate with manufacturers, principals, and internal departments to obtain technical and regulatory documentation required for product registration.
- Monitor regulatory changes, guidelines, and NPRA circulars, and assess their impact on the company's product portfolio.
- Maintain regulatory databases and ensure all product licenses, certificates, and supporting documents remain current.
- Support the preparation of responses to NPRA deficiency letters within the required timelines.
- Provide regulatory support to business development, procurement, marketing, and quality assurance teams.
- Participate in internal audits and regulatory inspections when required.
- Perform other regulatory-related duties assigned by the Regulatory Affairs Manager.
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