Position Overview
Your mission
Regulatory Affairs:
Maintain lifecycle for existing products, including license renew, PMF renew, post-marketing variations, etc.Support product license registration and PMF registration.Contribute to the discussion of registration plan with both local and global stakeholders.Monitor Regulatory regulations and communicate relevant updates to related stakeholders.Pharmacovigilance
Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for medical care products.Perform local literature search and report the identified adverse event.Manage submission/distribution of safety reports/updates to Local Health Authorities.Health Safety Environment (HSE)
Support in maintaining comprehensive HSE management systems, including identifying hazards and implement controls to mitigate risks.Coordinate the HSE training programs to emp...