1. Responsible for over-all regulatory functions
2. To co-ordinate global CMC submission. Support to the filling of the Regulatory dossiers globally coordinating with concerned Regulatory Agencies.
3. Liaison with ILRA and formulate the regulatory.
Hand on experience on API regulatory Affairs.
Knowledge of US/ Europe Market .
Keep the relevant inter-department(s)/ cross-functional teams abreast with the latest regulatory update with regard to regulatory guideline and requirements in different