Regulatory Affairs Assistant (temp 6 months)

Functional Skills and Knowledge:

• Bachelor’s degree in Medical or Pharmacist related discipline.
• Minimum 1 to 2 years experience in a similar role.
• Good communication in English is preferable.
• Capable of working independently and as a part of a team.
• Hardworking, eager to learn, and trustworthy.
• Proficient in Microsoft Office

Benefits:

• Monthly salary and yearly bonus
• Health insurance, social insurance, 24/24 insurance
• Annual leaves, sick leaves, child-care leaves, ...
• National holidays off including Christmas
• DKSH Personal Development Program for employees
• MBA sponsorship program

General Responsibilities:

• Review of safety information published in the scientific literature.
• Processing and reporting spontaneously received post‐marketing safety data including its receipt, tracking, coding, assessment, and submission to regulatory authorities.
• Maintenance of cumulative safety data received from all sources including spontaneous reports, literature sources.
• Assist RA manager on the registration service of products to Clients
• Consult on regulation to Clients/ relevant depts as assigned by the RA manager.
• Supports RA management to make the report to management/ report to Health authority.
• Other tasks of arranging data, reports, translating, and researching.