Regulatory Affairs Specialist

“Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.” Coordinate efforts associated with the preparation of regulatory documents or submissions.Assist in coordinating / preparing and reviewing regulatory submissions for Parkville’s products in addition to following up the customs clearance whenever needed.Keep up to date with economic / registration and submission changes in addition to maintaining regulatory documentation databases and following up any new decisions issued by the Ministry of Health / CAPAMake usual visits weekly to the Ministry of Health to check the pipeline status in order to full fill 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.Response to the governmental agencies’ requests for any information required such as product data and written regulatory affairs statements.Review product labeling/batch records/packs / licensing variation/specification sheets and test methods for compliance with applicable regulations and rules.

Education: Bachelor’s degree from reputable university {Degree in Pharmacy, Veterinary Medicine, Science is an advantageExperience: Previous experience in Pharmaceuticals industry {from 2-4 years in the same position / responsibilities}.