Regulatory And Clinical Specialist

Davipharm (Dat Vi Phu Pharmaceutical JSC)

Bến Cát, Binh Duong

Job description:

• Prepare registration dossier.

• Receive deficiency letter, analyze and make plan to answer. Compile, prepare and submit amendment dossier.

• Scientific support for clinical and bioequivalence assessment for research and development activities

• Advise and prepare pre-clinical and clinical documents

• Prepare safety and efficacy report for products required as per related regulation

• Make report as required by RA manager.

Job requirement:

• Degree in Pharmacy

• Know basic principles in drug development, quality control, quality assurance related to drug registration

• Ability to analyze and solve problems

• Ability to perform multiple detailed, concurrent tasks

• Ability to work under pressure and intensive deadlines

• Ability to work in a self-directed manner

• MS Office: Ability to use basic function of Word, Excel, Powerpoint

• English: Has ability to listen, speak, write, read, and translate

• Accuracy and attention to detail

• Excellent verbal... More Detail

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