Regulatory Affairs Specialist
صيدليات انوفا - Innova Pharmacy · Riyadh Region
قدّم وتابع مع أبلاي إيدجAbout the Company:Innova Healthcare Company was established in 1994 as an extended company under the Health House pharmacies, with branches throughout the capital, Riyadh.The group began to expand in the central region of Qassim and Hail, and branches were opened in the western region of Makkah Al-Mukarramah. We strive to be present soon in all regions of the Kingdom. Our vision focuses on improving and strengthening pharmaceutical activities, personal care requirements, and health services. With the slogan "Towards Better Health," Innova Healthcare prioritizes the health of its customers and, through its services and activities, helps achieve a better and healthier lifestyle.Job Responsibilities:1. Prepare, compile, and submit technical files for product registration, renewal, or variation to the Saudi Food and Drug Authority (SFDA).2. Ensure that all documentation complies with SFDA regulations and GCC guidelines3. Provide technical support regarding the registration and marketing of medicines, medical devices, foods, and cosmetics.4. Follow up on applications submitted through platforms like GHAD, SDR, or FASEH.5. Respond to SFDA queries, deficiencies, and feedback in a timely manner.6. Communicate with the SFDA and other parties to facilitate the certification process.7. Coordinate with foreign manufacturers to obtain and verify regulatory documentation.8. Collaborate with internal teams to ensure compliance with regulatory requirements.9. Review and approve product labels, packaging, and promotional materials to ensure alignment with SFDA requirements.10. Translate and verify Arabic content for accuracy and compliance.11. Assist in obtaining necessary import permits and customs clearance documentation.12. Manage company and warehouse license renewals and updates.13. Maintain accurate and organized regulatory records, submissions, approvals, and correspondence14. Maintain an up-to-date understanding of SFDA guidelines and anticipate potential regulatory changes.Required Qualification:1. Bachelor's degree in pharmacy.2. Saudi national and licensed pharmacist.3. At least 2 years in regulatory affairs.