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PR/158098 | Regulatory Affairs Pharmacist (RA, PV & QA)
| Location | Malaysia, Kuala Lumpur |
| Job Type | Permanent Full-time |
| Salary | Negotiable, based on experience |
Job Description
- Staying informed about regulatory requirements, ensuring compliance, and communicating with global, regional, and local teams.
- Handling safety event reviews and submissions to both Global Pharmacovigilance and local health authorities.
- Managing registration dossiers for regulatory approvals and maintaining local licenses.
- Evaluating change requests and their regulatory impact.
- Reviewing product labeling for compliance with branding and regulations.
- Leading or supporting local Good Distribution Practice (GDP) inspections.
- Assisting in addressing deviations and product complaints while monitoring their resolution status.
- Degree in Pharmacy with minimum 1-2 years experiences in RA and/or PV in pharmaceutical industry. Malaysian licensed Pharmacist preferred.
- Strong organizational and process management skills. Able to multi-task effectively.
- Proven ability to effectively build lasting relationships by demonstrating strong interpersonal and influencing skills throughout all levels of the organization.
- Teamwork and collaboration with cross functional teams.
- Excellent verbal and written communication skills in English.
General Requirements
| Minimum Experience Level | Over 3 years |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Business Level |
| 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 |
Job Category
- Other > Other
