Regulatory Affairs Specialist

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.