Evaluate, prepare and submit drug registration applications and follow through the application during the evaluation phase to achieve a favorable outcome.
Prepare applications for registration of new products, variations to marketed products and renewals, where required.
Assist with responses to deficiency letters and other requests for data from Saudi Food and Drug Authority.
Maintain registration of currently approved products.
Develop and maintain good working relationships with internal departments, health authorities and industry bodies.
Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products.
Develop packaging for new and existing products and comply with government regulations.
Review labelling and product information for compliance with relevant regulations and codes.
Liaise with manufacturing sites when required.
Update the pharmaceutical companys regulatory systems.
Authoring and reviewing standard operating procedures (SOPs) related to regulatory activities.
Reviewing and approving promotional and non-promotional materials.
Processing with any regulatory tasks.
Support in the business transition activities.
Support in initiating, processing, and archiving purchase orders and update the systems for regulatory payments.
Ensure that all regulatory trackers and systems are updated.
