Regulatory Affair Executive
• Prepare full 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 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 Junior RA specialist/ Senior RA specialist/ Junior RA executive. Review the quality of the registration dossier.
• Make report as required by RA manager
• Bachelor’s 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/ Drug quality control, quality assurance (that related to drug registration).
• Ability to analyze and solve problems
• Ability to work under pressure and intensive deadlines
• Ability to guide and support the lower-level staff
• Fluent English skill: Fluent in speaking, writing, reading, and translating.
• Good at MS office
Please contact our Recruiter or apply via email firstname.lastname@example.org