Company and Job Overview
A global pharmaceutical company is seeking a Specialist, Regulatory Affairs, Quality Assurance, and Pharmacovigilance. In this role, you will serve as the primary point‑of‑contact for all Regulatory Affairs (RA), Pharmacovigilance (PV), and Quality Assurance (QA) activities in Malaysia.
Job Responsibilities
Manage regulatory submissions, NPRA communications, labeling/artwork compliance, and maintenance of licenses (e.g., Import, Wholesaler)
Lead QA activities such as product release, GDP/GMP compliance, audits (internal, external, NPRA, HQ), and handling product quality issues
Maintain and oversee the Company’s PV system, ensuring ICSRs reporting, compliance with Malaysian and global PV requirements, and leading PV audits
Coordinate with Regional HQ, distributors, and manufacturers on RA/QA/PV matters, resolving regulatory issues or potential supply disruptions
Draft, review, and manage all RA/QA/PV-related agreements, SOPs, PSMF, and process improvements
Support broader organizational needs, including regional projects, CCM nominee director responsibilities (if required), and stakeholder management
Job Requirements
Bachelor of Pharmacy (B.Pharm) degree
Minimum 3–4 years of experience in regulatory affairs for pharmaceutical products in Malaysia
Registered Pharmacist in Malaysia
Experience in handling Quality Assurance (QA) and/or Pharmacovigilance (PV) activities
Strong knowledge of Malaysia’s pharmaceutical regulations, including RA, QA, and PV requirements
Familiarity with regional (ASEAN) and global regulatory landscapes
Good understanding of GMP, GDP, and GVP guidelines
Ability to work effectively with cross-functional teams, with a sound understanding of commercial operations within the pharmaceutical industry
Must be a Malaysian citizen or possess valid residency status
Interested applicants, feel free to click APPLY NOW
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