Regulatory Affairs Specialist

Parkville Pharmaceuticals -
Giza, EgyptPosted 10 months ago

186Applicants for1 open position

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Coordinate efforts associated with the preparation of regulatory documents or submissions.
Assist in coordinating/preparing and reviewing regulatory submissions for Parkville’s products and following up on customs clearance whenever needed.
Keep up to date with economic / registration and submission changes in addition to maintaining regulatory documentation databases and following up on any new decisions issued by the Ministry of Health / CAPA.
Make regular visits weekly to the Ministry of Health to check the pipeline status to fulfill any comments/modifications required from MOH within the registration phase or the variation phase of the products.
Obtain/distribute updated information regarding domestic laws/guidelines or standards.
Review product specifications for compliance with applicable regulations and rules in addition to preparing purchases.
Response to the governmental agencies’ requests for any information required such as product data and written regulatory affairs statements.
Keep track of the progress of regulatory submissions to Complete regulatory submission forms within the assigned time frame.
Review product labeling/batch records/packs/licensing variation/specification sheets and test methods for compliance with applicable regulations and rules.

Bachelor’s degree from a reputable university {Degree in Pharmacy, Veterinary Medicine, Science is an advantage}.
Experience Previous experience in the Pharmaceuticals industry {from 3-4 years in the same position/responsibilities}