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.
• 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.

Job requirement

• Bachelor degrees in Pharmacy
• At least 2 years’ experience in regulatory affairs position
• English: good at listening and speaking
• 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, concurrent tasks

Please contact our Recruiter or apply via email recruitment@adamed.com