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M t cng vic
Developing, reviewing, and implementing product registration plans for current and target markets.
Assigning tasks, supervising, and supporting the Regulatory Affairs team in preparing complete and accurate registration dossiers, especially for animal vaccine products.
Overseeing the registration process and maintaining communication with relevant authorities until certificates of registration or marketing authorizations are issued.
Liaising with and maintaining strong relationships with regulatory and government bodies, including the Department of Animal Health, Drug Administration of Vietnam, and Vietnam Food Administration.
Ensuring all registration dossiers comply with current legal and regulatory requirements for each target market.
Monitoring the dossier review process and coordinating timely responses to additional requests, clarifications, or feedback from authorities.
Managing the submission of import/export recommendation letters to the Ministry of Agriculture and other relevant authorities when required.
Providing regulatory support to internal departments such as R&D, Production, Quality, and Sales.
Preparing monthly reports on the status of all ongoing registration processes.
Performing other tasks or projects assigned by the Country Head related to the Regulatory Affairs function
Yu cu cng vic
Bachelor's degree in Veterinary Medicine, Pharmacy, Biotechnology, Biology, or a related scientific field (Master's degree preferred).
Minimum 8 years of experience in Regulatory Affairs within the animal health, pharmaceutical, biological, or vaccine industry.
At least 35 years of managerial or supervisory experience, leading regulatory or technical teams.
Strong knowledge of Vietnamese regulatory frameworks, particularly those related to animal vaccines, biologicals, pharmaceuticals, and feed additives.
Proven experience working with Vietnamese regulatory authorities in the field of vaccines, and pharmaceuticals.
Demonstrated expertise in preparing and submitting registration dossiers for animal vaccines and other biological/pharmaceutical products.
Familiarity with GMP, WHO/WOAH guidelines, import/export regulations, and registration procedures for both locally produced and imported products.
Excellent skills in regulatory planning, documentation, risk assessment, and compliance management.
Strong interpersonal and communication skills, with the ability to maintain effective relationships with government bodies and internal stakeholders.
Native proficiency in Vietnamese with strong English skills (written and spoken) is required.
Phc li
Salary negotiable at a senior management level
health insurance packagewith family
Flexible working time
Job ID: 136236383