- 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}