Regulatory Affairs Coordinator (Temporary)

תיאור משרה

We are hiring a Temporary Regulatory Affairs Coordinator who will support the activities of the RA team, including but not limited to handling documents, placing orders with suppliers, managing packaging and office supply inventory, and performing general office tasks. The role also includes fulfilling additional assignments as requested by the direct manager.

Responsibilities
Preparing registration portfolios (new, renewal, and update) for submission to the MOH, and updating tracking charts for each product.
Coordinating deliveries to the MOH and managing fee payments.
Preparing packaging graphics in collaboration with the registration pharmacist, graphic designer, and manufacturer.
Preparing user manuals for submission in accordance with MOH regulations, and coordinating review and approval with printing presses and manufacturers.
Sending documents for translation and coordinating with translators and manufacturers; performing translation and proofreading in English.
Ordering packaging materials and office supplies.
Monitoring the validity of approvals for new and existing customers.
Preparing regulatory submissions (new, renewal, and update) for the MOH.
Preparing packaging artworks in collaboration with the registration pharmacist, graphic designer, and manufacturer.
Preparing leaflets and artworks for submission in accordance with MOH regulations and coordinating further approvals with manufacturers.
Tracking and updating RA activities in the SharePoint system and internal tracking tables.
Printing letters and various pharmaceutical-related requests.
Performing additional tasks as requested by the direct manager.