Regulatory Affairs Officer

Purpose: This position is for registration and other relevant regulatory activities of AC, IC products (medical device and biocide)
Task and responsibility:
1. Update regulation/ internal process of local HA regarding registration activities
- Cooperate with local marketing to get confirmation on registration needs and request required documents for registration
- Assess dispatched documents, and prepare dossiers for submission
- Submission of the registration dossier, follow up and submit supplement dossier if any to get approval
- Request, prepare, submit, and follow up variation dossiers as change management
2. Update regulation/ internal process of local HA regarding registration activities
- Understand clearly all the current regulations regarding product registration including medical devices and biocides, and update and implement new regulations if any
- Understand all internal processes of local HA (IMDA, VIHEMA) regarding evaluation activities of registration. update and adapt timely
- Update and share with the team and relevant department for implementation
- Cross-function support including tender support and collaboration with SCM for the importation of registered products
3. Provide and order required documents as per LSM request for tender
- Coordinate with LSM, and SCM for the importation of registered products, and provide legal or technical documents to them for their process.
4. AW development
- Do artwork development after getting approval for product registration for production
- Do keep informing SCM of the progress of the AW development implementation timeline for placing orders and any changes if any