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Regulatory Specialist @ Getzhealthcare

HanoiOnsiteFull-time
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About this 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 protected] – Cell phones: 0389900995

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