- Manage new applications submission corresponding to company plan as well as the authority guidelines for submission.
- Manage review and submission of all maintenance activities (renewal & variations) based on company plans and the authority guidelines.
- Maintain the products labelling up to date
- Following strictly all the Authority Regulations, decisions & decrees.
- Carry out all communication and follow up required with EDA and internally
- Familiar with all regulations to support day to day activities.
- Respect quality and compliance aspects.
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BSC in pharmacy experience From 1-3 years of regulatory affairs Knowledge of preparation of CTD files/ dealing with Extedo programWorking in regulatory affairs in different export countries is an add