“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 / CAPA
- Make 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}.