Regulatory Affairs Specialist

About us:
The position is based in Ho Chi Minh City. You will work at URGO Group, a French healthcare company with a presence in Vietnam for nearly 30 years. You will join the affiliate team in Vietnam, supporting the Consumer Healthcare business and ensuring regulatory compliance for a portfolio of cosmetics, food supplements, and medical devices.
We are committed to delivering innovative health solutions to consumers, patients, and healthcare professionals while maintaining the highest standards of quality, safety, and compliance.
Specialized Industry: Scientific & Commercial - Pharma / Dermo-Cosmetics / Beauty / Medical Devices
Report directly to: Regulatory Affairs Manager
Main Responsibilities:
The Regulatory Affairs Specialist is responsible for managing product registrations and regulatory compliance activities for cosmetics, food supplements, and medical devices in Vietnam. The role ensures timely product approvals, compliance with applicable regulatory requirements, and effective support for product lifecycle management. Working closely with local, regional, and global stakeholders, the position contributes to successful product launches, market continuity, quality compliance, and the achievement of business objectives while safeguarding the company's regulatory standards and reputation.
Key Responsibilities:
Product Registration:
Compile and submit regulatory dossiers for cosmetics, food supplements, and medical devices to local authorities in a timely manner, including new product registrations, variations, renewals, and other relevant submissions.
Monitor changes in Vietnamese regulatory requirements and assess their impact on existing and future registrations.
Maintain regulatory databases and product registration records to ensure information is accurate, complete, and up to date.
Liaise with Regional and Global Regulatory Affairs teams as well as manufacturers to obtain required documentation and ensure compliance with registration requirements.
Collaborate with cross-functional teams to support product launches and maintain market continuity.
Support the Regulatory Affairs Manager in implementing regulatory projects and ensuring compliance with applicable regulations, guidelines, and standards.
Labeling Compliance:
Coordinate with Marketing, Logistics, and external partners to review and approve product labels, instructions for use (IFU), and packaging artwork in compliance with local regulations.
Advertising and Promotional Materials:
Review and approve advertising, promotional, and marketing materials to ensure compliance with approved product claims and applicable local regulations.
Regulatory Support:
Provide regulatory support and documentation to Commercial, Marketing, Market Access, and other relevant stakeholders.
Prepare regulatory assessments and recommendations for new business initiatives and product launches.
Customer Complaints and Vigilance:
Coordinate with local business partners, manufacturers, and Regional/Global Quality Assurance teams to manage customer complaints according to company procedures and local regulations.
Assess and report adverse events, product incidents, and safety-related issues to local authorities as required.
Quality System Support:
Participate in Change Control, Deviation Control, CAPA, and Document Management activities.
Support internal and external audits related to regulatory compliance and quality management systems.
Requirements:
Education:
Bachelor's degree in Pharmacy, Biotechnology, Biomedical Sciences, or a related discipline.
Working experience:
3-5 years of relevant experience in the cosmetics industry preferred.
Experience in food supplements and medical devices will be an added advantage
Technical Knowledge:
Good understanding of Vietnamese regulations governing cosmetics, food supplements, and medical devices.
Knowledge of EU regulations and international regulatory requirements would be an advantage.
Ability to interpret regulations, guidance documents, and technical standards.
Skills:
Strong organizational and project management skills.
Ability to work independently and effectively in a cross-functional environment.
Proficiency in Microsoft Office applications and regulatory documentation management.
Good written and spoken English communication skills.