Regulatory Affairs Specialist

• Prepare the registration documents for initial registration/new registration, renewal, supplementation, changes, and GMP evaluation for pharmaceuticals in the treatment of various fields such as Oncology, Cardiology, Gastroenterology, Neurology, Respiratory.

Rà soát, lập hồ sơ đăng ký để gia hạn/đăng ký lần đầu/bổ sung/thay đổi/đánh giá GMP kịp thời.

• Reporting to the RA manager to...

Yêu cầu công việc

- Bachelor’s Degree in Pharmacy or related field

- Strong knowledge of pharmaceuticals, medical products, and regulatory requirements

- At least 3 years of hands-on experience in Drug Registration/Regulatory Affairs

- Good command of English with strong communication and coordination skills

- Detail-oriented, proactive, and able to work effectively with regulatory authorities and internal stakeholders