Regulatory Specialist

Responsibilities:

·       Carry out all procedures related to product registration for market circulation, including renewal registrations, variation/amendment registrations, new registrations, and import quota applications, and submit dossiers to the relevant regulatory authorities (Ministry of Health).

·       Manage import licenses, develop plans, and execute timely renewals to ensure the continuous distribution of existing products.

·       Work directly with suppliers and manufacturers to collect the documents required by the Ministry of Health for import license registration and for completing tender dossiers when requested.

·       Monitor and report on progress with suppliers and the registration status of products.

·       Provide necessary information and documentation as requested by colleagues and regulatory authorities (including the Ministry of Health), ensuring compliance with company policies and legal requirements.

·       Support the Sales Department by preparing and providing tender documents for hospitals and healthcare facilities.

·       Monitor and update changes in Ministry of Health regulations related to import license registration and communicate relevant updates to management and concerned departments.

Qualifications:

• Bachelor's degree in Chemistry, Biology, Pharmacy, or other related fields.
• Candidates with knowledge of healthcare and pharmaceutical regulations/laws are preferred.
• At least 2 years of experience in Regulatory Affairs (RA) is an advantage.
• Proficient in Microsoft Office applications.
• Good English communication skills.
• Careful, proactive, quick to learn, and able to adapt to new knowledge and processes.
• Ability to work independently while maintaining a strong teamwork-oriented mindset.

Benefits

• Competitive salary, commensurate with qualifications and experience.
• Annual salary review and promotion opportunities based on employee performance and capabilities.
• 13th-month salary bonus.
• Full participation in Social Insurance (SI), Health Insurance (HI), and Unemployment Insurance (UI) based on the full salary.
• Bao Viet private healthcare insurance coverage.
• Annual company trips and health check-ups.
• Friendly, cooperative, and supportive working environment.
• Working schedule: Monday to Friday.

Workplace:

Hanoi Office: Room B12-14, 4th Floor, T2 Times Tower, 35 Le Van Luong Street, Nhan Chinh Ward, Thanh Xuan District, Hanoi, Vietnam

Contact Information: Mrs. Lan – Email: lan.vo@getzadvanced.com – Cell phones: 0389900995