Regulatory Affairs Specialist

Lương không công khai

Hà Nội+1

Nghỉ trọn T7, CN

Hạn chót 01/10/2026

Đăng 27 ngày trước

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

Công việc cụ thể là gì?

• 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. • Reporting to the RA manager to implement Regulatory Affairs activities. Complete relevant reports within designated timeframes. • Ensures that all product labels/package inserts are updated as approved by MOH’s regulation. • Ensure the commercial CoAs are comply with approval documents • Arranging and Recorded registration dossier as current regulation. • Liaise and work with the Drug Administration of Vietnam (DAV) and relevant authorities • Communicate with Head Office regarding registration dossiers/documents • Support the handling of additional document requests from regulatory authorities • Other tasks requested by Manager. • Ngày làm việc: T2 - T6 • Giờ làm việc: 08:00 - 17:00 • Cấp bậc: Có kinh nghiệm • Loại công việc: Toàn thời gian

Quyền lợi có gì?

Hetero Labs Limited

Dịch vụ Y tế/Chăm sóc sức khỏe

Hetero is one of India’s leading generic pharmaceutical companies and is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. With more than 20 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas include APIs, generics and biosimilars. Hetero also offers custom pharmaceutical services to its partners around the world. The company is recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products. Hetero has more than 25 state-of-the-art manufacturing facilities strategically located worldwide. Majority of our facilities have been successfully audited and approved by stringent regulatory authorities like US FDA, EU, TGA-Australia, MCC-South Africa and others. Our portfolio includes more than 200 products, encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, etc. Hetero has a strong global presence in over 120 countries and focusses on making affordable medicines accessible to patients worldwide.

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