Regulatory Affairs Officer

Job Description:

The candidate will be responsible on the following:

• Responsible for ensuring the establishment license and registrations of Food and Drug Administration (FDA).
  • On-time submission of initial, renewal and variation of licenses and product registrations
  • Obtain on-time product registration approval from regulatory agency
  • Compliance / Audit Findings / Post Licensing / Post Marketing Surveillance
  • Accomplish Special Projects – SOP, Database, Product survey/testing

Job Qualifications:

He/She must also meet the following qualifications:

• College Graduate (Bachelor of Science in Pharmacy)
• Professional Regulation Commission License
• Holder of Qualified Person in Regulatory Affairs Accreditation (QPIRA) is a plus