RESPONSIBILITIES:
-Product Registration:
- Timely compile and prepare regulatory documentation for submission of Medical Devices to local authorities. This includes new product registration submission, variation to registered products, license renewal, etc.
- Monitor changes in the Vietnam regulatory framework to facilitate ongoing registration activity.
- Maintain updated RA databases of registered products and documentation to ensure information is accurate and up to date.
- Assist RA manager in communication with RA departments of Regional and Global as well as RA departments of corresponding manufacturers.
- Work collaboratively with cross-function team to ensure regulatory compliance and market continuity.
- Support RA manager in formulation of regulatory projects and keep abreast of local regulation, guidance and standards applicable to URGO's products.
-Goods Label: coordinate with Marketing/Logistics/Importers to review and approve labeling, direction for use and user manuals for the country in compliance with local regulations.
-Advertisement: coordinate with Marketing team to review and approve advertising/promotional materials developed in Vietnam for compliance with product claims and local regulations.
-Regulatory Support:
- Ensure updates of proper documentation as requested by Field Force/Market Access/Marketing/Logistics
- Provide administrative support in terms of Regulatory Affairs to relevant departments
-Management of Customer Complaint and Adverse Event:
- Work with local business partners and QA departments of Regional and Global as well as corresponding manufacturers to handle customer complaints according to local regulations and Urgo requirements.
- Report to local authority if there is any reportable adverse event related to URGO products.
-Change/Deviation Control
-Document Management
REQUIREMENTS:
- Education/Certifications: minimum a bachelor's degree in pharmacy, biotechnology or biomedical sciences.
- Working experience: about 2 years in a regulatory affairs environment.
- Demonstrated knowledge of regulatory issues, and experience interfacing with local regulatory bodies. Experience with EU regulations of medical devices will be an advantage.
- Ability to read, analyze, and interpret governmental regulations and reports.
- Work independently as well as in a team with relevant departments.
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Good communication skills in English.
