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Regulatory Specialist
getzhealthcare · Hanoi, Vietnam
About The Role
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: [email hidden] – Cell phones: 0389900995
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