Position - Regulatory Affair Assistant Manager/ Executive (M/F - 1 Post)
Salary - Up to 1,300,000 MMK + Attendance Allowance, Communication Allowance + Uniform
Business - Pharmacy Distribution
Working Days & Hours - Monday to Friday (9:00 AM ~ 5:00 PM), Sat (9:00 AM ~ 1:00 PM)
Location - Bahan Township
Job Description:
- Check the ACTD Dossier, prepare and submission of all documents for drug and food supplement according to the MMFDA requirements
- Prepare the sample permit application and one time permit application
- Checking samples for new and renewal drug registration
- Sending samples to NPT
- Communicate with Principle for registration requirements
- Maintain records of FDA submission and registration status
- Ensure to keep changes in Myanmar FDA guideline
- Regular monitor on the license active (Wholesale and Retailed license, DIAC Certificate, UMFCCI Certificate, MCCPMD Certificate)
- Review and report overall registration status to the management team on weekly
Job Requirement
- Bachelor Degree in M.B.B.S or B Pharm
- Three to Five years in FDA regulatory field for Assistant Manager
- Experience in Regulatory Field is more preferable for Executive but fresh graduate are also welcome
- Effective Communication skills, able to create good employee relationship
- Initiative and highly motivated