Drug Regulatory Inspector
やくじかんしいん
Industry & Occupation
Classification
Summary
Specialist who monitors legal regulations on the manufacturing, distribution, and use of pharmaceuticals to ensure safety and quality.
Description
Drug Regulatory Inspectors ensure the safety and quality of pharmaceuticals by conducting audits of manufacturing and sales companies and clinical trial facilities, reviewing marketing authorization application documents, and analyzing adverse event reports. They verify compliance with the Pharmaceutical and Medical Device Act (formerly the Pharmaceutical Affairs Law) and GMP/GCP/GVP standards, and issue corrective instructions or improvement proposals as needed. They typically work in pharmaceutical companies, regulatory authorities, or public institutions, requiring advanced specialized knowledge and understanding of regulations.
Future Outlook
With stricter pharmaceutical regulations and strengthened compliance with global standards, demand for specialized drug regulatory monitoring personnel is expected to increase in the future. As AI-driven safety data analysis and risk prediction technologies advance, the market value of personnel with specialized knowledge will rise.
Personality Traits
Cautious and accurate / High ethical standards / Patient / Strong sense of responsibility
Work Style
Business trips involved / Office work / Pharmaceutical company employment / Public institution employment
Career Path
Junior Regulatory Officer → Senior Regulatory Officer → Manager (RA/QA) → Department Head → Regulatory Authority Auditor
Required Skills
Adverse Event Report Management / GMP Knowledge / Pharmaceutical Regulatory Knowledge / Regulatory Application Procedures
Recommended Skills
English Literature Reading / Internal Audit Knowledge / Statistics
Aptitudes (Strengths Preferred)
| Item | Description |
|---|---|
| Analytical & Logical Thinking | Because it is necessary to analyze regulatory requirements and safety data. |
| Attention to Detail & Accuracy | Because it is necessary to check every detail accurately when monitoring legal compliance. |
| Learning Agility & Knowledge Acquisition | Because it is necessary to continuously learn about ever-amending pharmaceutical regulations and guidelines. |
Aptitudes (Weaknesses Acceptable)
| Item | Description |
|---|---|
| Creativity & Ideation | Because tasks are performed in accordance with established rules. |
| Physical Stamina & Endurance | Primarily desk work with minimal heavy labor. |
Related Qualifications
- Pharmacist License
Related Jobs
- Pharmacist
- Quality Control Officer
- Regulatory Authority Auditor