Regulatory Affairs Associate – Senior Level (On-Site)

Job Purpose:

1.Prepare and submit regulatory documents compliance with THAI-FDA guideline for New 

product registration, post approval changes, and renewals, including Drug registration for export product in Asian countries, EU country.

2. Responsible for renewal company's license, GMP clearance, GDP, FDA report.

3. Prepare and submit Advertising document to THAI-FDA within Marketing time plan

4. Review and correct proof art work, package labeling compline with regulatory standard. 

5. Responsible for pharmacovigilance activity, SMPC, PIL, RMP with regulatory standard

6. Quality document review for support the import product shipment/clearance in terms of certificate of Analysis/GMP Certificate/ISO Certificate for product release and ensure compliance with Regulation rules.

7. QA activity in change control related in regulatory requirements, internal audit 

8. Prepare and submit Dietary supplement registration and familiar with THAI-FDA cultural

   System and friendly discussion/communicate with THAI-FDA officer for carried the project within time plan

9. Well communicate with Clients in English both speaking and writing for achieved the project 

• Product type: Pharmaceutical product, Dietary supplement, Animal Drug, Cosmetic, Herbal medicine

Qualifications & Experience:

• Bachelor’s degree in Pharmacy with license.
• Experience 1-3 year in Drug product registration/QA-QC quality system.
• Experience in Dietary supplement registration
• Proficient in oral and written in English. 
• Computer literacy (Word, Excel, PowerPoint).
• Accurate, service mind and proactive.
• Proven good coordinator and communication skills.