Regulatory Affairs & Registration Officer

Regulatory Affairs & Registration Officer Location: Muscat, Sultanate of Oman Employment Type: Full-Time Department: Regulatory Affairs We are seeking a detail-oriented and motivated Regulatory Affairs & Registration Officer to join our team. The successful candidate will be responsible for managing product registration activities, regulatory submissions, and ensuring compliance with the applicable regulatory requirements of the Ministry of Health in Oman. Key Responsibilities • Prepare, compile, and submit regulatory dossiers for pharmaceutical and medical products. • Manage new product registration, renewals, variations, and post-registration regulatory activities. • Coordinate with the Ministry of Health (MOH) and other relevant regulatory authorities. • Review product documentation, including certificates, licenses, product information, and technical documents. • Follow up on regulatory submissions and respond to queries from regulatory authorities. • Ensure compliance with local regulatory requirements and applicable guidelines. • Coordinate with international manufacturers and suppliers to obtain required regulatory documents. • Maintain and update product registration records, licenses, and regulatory databases. • Monitor regulatory updates and communicate changes to relevant departments. • Ensure timely completion of regulatory submissions and registration procedures. Qualifications & Requirements • Bachelor's degree in Pharmacy or a related pharmaceutical/health science field. • Previous experience in Regulatory Affairs and Product Registration is preferred. • Knowledge of pharmaceutical registration requirements and MOH regulations in Oman. • Familiarity with CTD/eCTD dossier preparation and regulatory documentation is an advantage. • Good understanding of pharmaceutical regulations, guidelines, and compliance requirements. • Proficiency in Microsoft Office. • Excellent written and verbal communication skills in English. • Strong organizational skills, attention to detail, and ability to meet deadlines. Required Skills • Regulatory Affairs • Pharmaceutical Product Registration • Regulatory Submissions (CTD/eCTD) • MOH Regulatory Compliance • Dossier Preparation & Review • License Renewals & Variations • Regulatory Documentation • Stakeholder Coordination How to Apply Interested candidates are invited to submit their updated CV to: Email : EMAIL_ADDRESS / EMAIL_ADDRESS Email Subject : Application Regulatory Affairs & Registration Officer • Bachelor's degree in Pharmacy or a related pharmaceutical/health science field. • Previous experience in Regulatory Affairs and Product Registration is preferred. • Knowledge of pharmaceutical registration requirements and MOH regulations in Oman. • Familiarity with CTD/eCTD dossier preparation and regulatory documentation is an advantage. • Good understanding of pharmaceutical regulations, guidelines, and compliance requirements. • Proficiency in Microsoft Office. • Excellent written and verbal communication skills in English. • Strong organizational skills, attention to detail, and ability to meet deadlines.