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
Qualifications
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
