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:

• Bachelors 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: Cell phones:

Required Experience:

Senior IC