Job Responsibilities
- 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 3 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.
