Job ResponsibilityJob Description:
o 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.
o Functional regulatory representative of the OEM Products manufactured by third-party (OEM) manufacturers to support regulatory submission and approval.
o Coordinated and ensured products approval in SEA countries.
o Product commercial supply, i.e., custom importation, clearance requirement, etc.
o Conducted dossier gap analysis and provided relevant regulatory advice by comparing the local dossier versus the latest ICH/ASEAN & other applicable Guidelines.
o Cosmetic GMP, GDPMD, ISO 13485 licensing establishment.
Job requirements:
Requirements:
o Candidate must possess at least a Diploma or Bachelor's Degree in pharmacy, biomedical sciences, biochemistry, biotechnology, Nutritionist or relevant science field.
o At least 3 year working experience in product submission and registration of schedule poison, OTC, health supplement or traditional medicine with NPRA.
o Priority will be given for candidates with Pharmacist License with 3 years work experience in Regulatory.
Job RequirementsJob Benifits
