Regulatory Affairs Specialist (Pharmaceuticals)

A. New registration Dossier Management: Manage the complete registration lifecycle from initial assessment through final approval; Work closely with manufacturers to ensure complete dossiers;

B. Post-Submission Management: Monitor dossier processing status following submission, update registration dossier status;

C. Additional Duties: Coordinate with Import-Export department for label, artwork, package insert review & process variation registrations;

COMPETENCY REQUIREMENTS

• Must be, at least, 4-year experience in Regulatory Affairs (Pharmaceuticals - in ready dossier for import products - prefer working in importing company);

• Proficiency in English; time management;

• Comprehensive knowledge of Vietnamese pharmaceutical regulations and ACTD format;

• Effective coordination and communication skills with stakeholders.

COMPENSATION & BENEFITS

• Salary negotiable based on experience and qualifications (discussed during interview process)

• Periodic salary reviews based on performance and company business results, bonuses for individual & team per dossier

• 13th month salary (possibly 14+) and social insurance coverage as per Vietnamese labor law

• Annual oversea company trip

• Long-term employment opportunities and professional development support

• Based on the experience & capability, it’s flexible to promote RA supervisor or manager and attractive benefit package accordingly after a few months

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To apply, please submit your detailed CV highlighting your pharmaceutical regulatory experience.

Head Office: District 1, Ho Chi Minh City