Regulatory Affairs Supervisor

Main Purpose of JobResponsible for the preparation, publishing, submission, and lifecycle management of pharmaceutical registration dossiers in compliance with SFDA and applicable international regulatory requirements in ARAC . The role ensures timely product registrations, variations, renewals, and maintenance of marketing authorizations through effective dossier management and eCTD publishing.Functional ResponsibilitiesPrepare and submit pharmaceutical registration dossiers to SFDA and other regulatory authorities. Manage registrations, variations, renewals, deficiency responses, and post-approval changes. Ensure compliance with CTD/eCTD requirements, SFDA regulations, and ICH guidelines. Monitor submission timelines and maintain regulatory trackers. Compile, publish, validate, and maintain eCTD submissions and lifecycle sequences. Ensure accurate document placement within Modules 1–5. Perform technical validation and resolve publishing issues. Maintain electronic regulatory archives and documentation. Review and organize regulatory documents received from manufacturers and business partners. Prepare application forms, labeling materials, product information, declarations, and other regulatory documents. Monitor regulatory updates and assess their impact on registered products. Support regulatory inspections, audits, and compliance activities. Job RequirementsQualificationsBachelor’s degree in pharmacy.Master’s degree in Regulatory Affairs or related discipline is an advantage.ExperienceMinimum 6 years in related field.LanguageRequired English - proficient.Preferred Arabic - proficient.