Regulatory Affair Assistant Manager (For a Well-Established Pharmaceutical Company)

Job Descriptions

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 Requirments

Bachelor Degree in M.B.B. S or B Pharm.
Minimum 3 to 5 years of working experience 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.

Other information

If you are interested in this job, please email your resume to hr@achievecareermyanmar.com or call 09454962773 for other information.

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