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
• Review technical documents of active pharmaceutical ingredients (APIs)

Job requirement:

• Bachelor’s degree in Pharmacy
• At least 1–2 years of experience in a related field (QA, R&D)
• Sufficiency knowledge in drug development, quality control, quality assurance related to drug registration
• Ability to analyze and solve problems
• Ability to handle multiple detailed tasks simultaneously
• Ability to work under pressure and meet deadlines effectively
• English: Basic listening and speaking skills; good reading, writing, and translation ability
• Excellent verbal and written communication skills
• Good teamwork skills

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