Regulatory And Clinical Specialist

Job description:

• Prepare registration dossier.
• Receive deficiency letter, analyze and make plan to answer. Compile, prepare and submit amendment dossier.
• Scientific support for clinical and bioequivalence assessment for research and development activities
• Advise and prepare pre-clinical and clinical documents
• Prepare safety and efficacy report for products required as per related regulation
• Make report as required by RA manager.

Job requirement:

• Degree in Pharmacy
• Sufficient knowledge in drug registration to perform most work in normal situation
• Know basic principles in drug development, quality control, quality assurance related to drug registration
• Ability to analyze and solve problems
• Ability to perform multiple detailed, concurrent tasks
• Ability to work under pressure and intensive deadlines
• Ability to work in a self-directed manner
• MS Office: Ability to use basic function of Word, Excel, PowerPoints
• English: Has ability to listen, speak, write, read, and translate
• Accuracy and attention to detail
• Excellent verbal and written communication skills
• Good teamwork skills.

Please contact our Recruiter or apply via email