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PR/160196 | Specialist, Regulatory Affairs, Quality Assurance and Pharmacovigilance
| Location | Malaysia, Kuala Lumpur |
| Job Type | Permanent Full-time |
| Salary | Negotiable, based on experience |
Job Description
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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General Requirements
| Minimum Experience Level | Over 3 years |
| Career Level | Mid Career |
| Minimum English Level | Fluent |
| Minimum Japanese Level | None |
| Minimum Education Level | Associate Degree/Diploma |
| Visa Status | No permission to work in Japan required |
Job Location
- Malaysia, Kuala Lumpur
Work Conditions
| Job Type | Permanent Full-time |
| Salary | Negotiable, based on experience |
| Industry | Pharmaceutical |
