Regulatory Affairs Associate
Mô tả công việc
Main Purpose of the Role
This role is responsible for providing regulatory affairs service mainly covering general consumer goods and cosmetics products. The role is responsible in preparing, submitting and maintaining accurate regulatory documents and approvals; monitoring regulatory and legislative changes, assessing their impact and risks, and providing clear guidance to ensure full compliance with product and ingredient requirements. The role will work with Manager to communicate KC policies & procedures and Vietnam regulations to cross‑functional teams, to ensure products, ingredients, claims, labels and advertising are compliant. This role also handles cosmetic PIF readiness, post‑market regulatory issues, supports local regulatory procedures and global QMS requirements as needed.
Job Description
Monitor and analyze regulatory changes in Vietnam; conduct risk and business impact assessments and communicate impacts to internal stakeholders.
Review advertising and promotional materials prior to release to ensure regulatory compliance.
Liaise with accredited certification bodies to secure and maintain conformity certifications as required by Vietnam regulations.
Manage regulatory compliance for consumer goods, cosmetics, and paper products across Baby & Child Care (BCC), Feminine Care, and Adult Care (AFC) categories.
Represent Kimberly- Clark Vietnam as a member of the Vietnam Cosmetic Committee (VCC) and work with regulatory authorities (DAV, DOH) on regulatory matters and policy interpretation.
Deliver regulatory training for cross- functional teams.
Coordinate with the Vietnam Drug Administration (DAV) for cosmetic product notifications and with the Department of Health to obtain advertising licenses.
Review and approve product claims and labeling, ensuring claims are truthful, non- misleading, properly substantiated, and fully compliant with Vietnam regulatory requirements.
Maintain and manage regulatory notifications, licenses, and certifications (RNC) and support Global Regulatory Affairs activities, including SOPs, Job Aids, CAPA, Regulatory Assessments, Product Review Boards, and Change Control processes.
Collaborate cross- functionally with Legal, Marketing, R&D, Quality Assurance, and Product Safety on new product launches, innovations, and change control projects.
Prepare and submit accurate, complete regulatory submissions and notification in a timely manner to meet business objectives.
Attend trade association meeting as KC representative as instructed by Manager.
Prepare, maintain, and ensure compliance of Product Information Files (PIFs) for cosmetic products before and after market launch.
Yêu cầu công việc
Experience in conducting regulatory assessments and reviews on product claims, product labels, advertisements.
Experience in conducting regulatory intelligence and regulatory monitoring.
Have experience & ability to analyse and interpret regulations effectively
Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
Ability to managing and executing regulatory projects in a timely manner.
Minimum of 2- 3 years of relevant experience in regulatory affairs within consumer goods or cosmetics industry.
Good communication skills, both written and verbal, to effectively interact with stakeholders and teams.
Have experience working with MOH, DOH, DAV, TCVN, QCVN & TCCS
Ability to work independently and manage regulatory compliance in Vietnam
Bachelor’s degree in Pharmacy, Science or Engineering.
Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation.
Quyền lợi
Laptop, Chế độ bảo hiểm, Chế độ thưởng, Chăm sóc sức khỏe, Đào tạo
Cập nhật gần nhất lúc: 2026-03-16 18:35:03











