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Job Description
A Multinational Pharmaceutical Company is hiring a Regulatory Affairs Specialist for one year job contract to be renewed if needed :
Plans the registration application under the leadership of the Regulatory Affairs manager
- Prepare the registration application files in accordance to the local regulations and to present it to Egypt FDA in order to register the new
- Products, which are determined by the Business Units under the supervision of the RA manager .
- Follows up the application deadline and gathers the required documentation from GRA.
- Follows up the evaluation processes at the MoH and ensures to fulfill their demands.
- Support the RA managers with the Medical Department for clinical trial and PV applications in terms of submission of the files and sharing the MoH's written correspondences.
- Ensure to prepare all documents related to registration of product and ensure whenever needed to presented to local authorities to follow up all related tasks.
Job Requirements
- University graduate in Pharma or relevant medical background
- At least 2 years of experience in regulatory affairs /PV and in dealing with local authorities
- V.Good English
