Regulatory Affairs / Quality Assurance Professional
Minimum : Bachelor’s degree in relevant fields
Preferred (senior roles) : MSc in Regulatory Affairs / Pharmaceutical Sciences / Public Health / Pharm.D / Ph.D.
Relevant disciplines include Life Sciences (Biology, Biochemistry, Microbiology), Pharmacy, Chemistry, Biomedical Science, medicine and nursing, Engineering (especially medical devices), or Law (for regulatory legal roles).
Skills & Knowledge
Experience
Entry-level : Fresh graduates with relevant degrees and internships / coursework in regulatory fields
Mid / Senior-level : 2–10+ years in Regulatory Affairs, QA, or Clinical
Malaysia-Specific Knowledge
Familiarity with NPRA, DCA, and MDA guidelines is highly preferred.
Additional Information
For your information, our company is currently engaging Pharmacosip Consultancy to support all external matters related to pharmaceuticals, food, and cosmetic products (e.g., registration, licensing, labelling compliance, advertising review, GDP documentation).
During Good Distribution Practice (GDP) audits conducted by the NPRA, it is generally required that an internal staff member (Responsible Person, RP) be present to :
Hence, we are particularly looking for candidates who can take on this Responsible Person (RP) role and fulfil these obligations during audits.
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Regulatory Assurance • Kuala Lumpur, Kuala Lumpur, Malaysia