Job description:

• Prepare registration dossier.
• Analyze, update current guideline, regulation to ensure the compliance of company. Offer general advice on regulatory strategy
• Receive deficiency letter, analyze and make plan to answer. Compile, prepare and submit amendment dossier.
• Find information and prepare pharmacology document, leaflet
• Manage drug MA (marketing authorization certification) of company that he/she in charge of. Take action (submit extension, variation dossier) to ensure the continuation of MA
• Guide and support lower-level staff. Review the quality of the registration dossier
• Make report as required by RA manager

Job requirement:

• Degree in Pharmacy
• At least 2 years’ experience in related field
• Thorough knowledge in drug registration: sufficient comprehension of the subject area to solve unusual as well as common work problems
• Sufficiency knowledge in drug development, quality control, quality assurance related to drug registration
• Ability to analyze and solve problems
• Ability to perform multiple detailed, concurent tasks
• Ability to work under pressure and intensive deadlines
• Ability to work in a self-directed manner
• Ability to guide and support the lower-level staff
• MS Office: Ability to use basic function of Word, Excel, Powerpoint
• English: Has ability to listen, speak, write, read, and translate
• Excellent verbal and written communication skills

Please contact our Recruiter or apply via email recruitment@davipharm.info