Regulatory Affairs Pharmacist
1 week ago
New product registration and regulatory filling plan for OEM Products including pharmaceutical products, medical devices, FMCG, etc. (MAL, MDA NOT and Food), in Southeast Asian countries.
- Functional regulatory representative of the OEM Products manufactured by third-party (OEM) manufacturers to support regulatory submission and approval.
- Coordinated and ensured products approval in SEA countries.
- Product commercial supply, i.e., custom importation, clearance requirement, etc.
- Conducted dossier gap analysis and provided relevant regulatory advice by comparing the local dossier versus the latest ICH/ASEAN & other applicable Guidelines.
- Cosmetic GMP, GDPMD, ISO 13485 licensing establishment.
Job requirements:
**Requirements**:
- At least 3 year working experience in product submission and registration of schedule poison, OTC, health supplement or traditional medicine with NPRA.
**Salary**: RM4,000.00 - RM5,000.00 per month
**Benefits**:
- Flexible schedule
- Opportunities for promotion
- Professional development
Schedule:
- Flexible hours
Supplemental pay types:
- Performance bonus
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