The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.
Provide professional regulatory advice to Medison’s business units and partners.
Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
Good relationships with regulatory authorities and Medison’s partners and advancing timelines in the registration processes.
Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
conditions.
Handling all types of submissions, new products, changes, and renewals.
Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
medical equipment and devices unit with registration requirements.
