Join our team and build your career with us
•Manage the end-to-end registration and maintenance of products with the Saudi Food and Drug Authority (SFDA) and other Gulf regulatory authorities (e.g., UAE).
•Prepare, review, submit regulatory documentation for food supplements, medical devices, IVDs and cosmetics.
•Ensure all regulatory submissions comply with current Gulf regulations & guidelines.
•Liaise with regulatory authorities to respond to queries and requests for additional information within required timelines.
•Coordinate with manufacturers and suppliers to collect and review technical documentation required for product registration.
•Prepare product artwork and Instructions for Use in compliance with Gulf regulatory requirements.
•Monitor changes in SFDA and Gulf regulations and assess their impact on existing and new products.
•Maintain accurate regulatory records and ensure timely renewal of product registrations, manufacturer licenses, and authorized representative agreements.
•Support cross-functional teams including Business Development and Supply Chain on regulatory requirements.
•Provide guidance and training to junior Regulatory Affairs Specialists and review their work before submission.
Track registration timelines and prepare regular progress reports for management.
Qualifications
•Bachelor’s degree in Pharmacy, Biotechnology, Medicine, or a related field.
•Minimum 2 years of hands-on experience in Regulatory Affairs with a strong focus on SFDA registrations.
•Practical experience with the GHAD system and Saudi regulatory submission processes.
•Experience in UAE regulatory registrations is highly preferred.
•Strong knowledge of regulatory requirements for food supplements, medical devices, IVDs, cosmetics, or pharmaceuticals.
•Ability to review technical documentation, product labels, certificates and regulatory dossiers.
•Excellent communication skills with international manufacturers and regulatory authorities.
•Strong analytical, organizational and problem-solving skills with attention to detail.
Ability to manage multiple projects and meet strict regulatory deadlines
