Job description:

• Prepare registration dossier.
• Receive deficiency letter, analyze and make plan to answer. Compile, prepare and submit amendment dossier for assigned dossiers.
• Review and assess API documentation for completeness, compliance, and suitability for variation submissions
• Coordinate activities related to API source variation with internal stakeholders and API vendors
• Maintain regulatory archives and master data
• Collaborate with QA to ensure GMP inspection readiness

Job requirement:

• Degree in Pharmacy
• At least 1–2 years of experience in a related field (QA, R&D)
• Knowledge in drug development, quality control, quality assurance related to drug registration
• Knowledge in drug registration: sufficient comprehension of the subject area to solve unusual as well as common work problems.
• Ability to analyze and solve problems, handle multiple detailed tasks and work under pressure and meet deadlines effectively.
• English: proficiency sufficient for technical document review and professional email communication with vendors/partners, listen and present in project meeting
• Excellent verbal and written communication skills
• Good teamwork skills

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