Regulatory Affairs Manager

Overview"Saudi Nationals Preferred" Our client, a leading Indian multinational pharmaceutical company, is seeking a Regulatory Affairs Manager/Specialist for their newly established facility in Riyadh, Saudi Arabia. This role supports Saudization initiatives and will focus on ensuring compliance with Saudi regulatory requirements.Job Title: Regulatory AffairsManager | SFDA -ExperiencedLocation: Riyadh, Saudi ArabiaReports to: Country ManagerIndustry: PharmaceuticalsNote: Candidate must have experience working with SFDA (Saudi Food & Drug Authority)Job SummaryThe Senior Manager – Regulatory Affairs will lead SFDA regulatory activities for Saudi Arabia, ensuring timely product registrations, lifecycle management, and ongoing compliance. The role acts as the primary liaison with SFD, PV, and Quality teams across product development, registration, and commercialization.Key ResponsibilitiesRegulatory Submissions & Lifecycle ManagementManage new registrations, renewals, variations, and deficiency responses with SFDAReview dossiers (incl. DMF), ensure compliance, finalize eCTD/SDR submissionsTrack approvals, handle appeals, and maintain product licenses across lifecycleReview and approve labelling, SPC, PIL, and bilingual artworksRegulatory Strategy & Portfolio SupportProvide regulatory input on portfolio selection, RLD availability, and filing routesSupport product development with early regulatory guidanceConduct regulatory due diligence for in-licensing and localization projectsRegulatory IntelligenceMonitor and communicate SFDA guidelines, circulars, and regulatory updatesAdvise on bioequivalence, biowaivers, exemptions, and complex filingsBenchmark industry practices and support strategy for complex productsSFDA Liaison & Stakeholder ManagementAct as single point of contact with SFDA for submissions, meetings, inspectionsArrange and participate in pre-submission meetings and inspectionsProvide regular status updates to internal stakeholdersMAH & Localization SupportSupport MAH responsibilities, PV coordination, brand name approvalsProvide input on patents, data exclusivity, tech transfer, and local manufacturingIdentify SFDA-approved packaging/manufacturing sitesDocumentation & TranslationOversee Arabic–English translations of dossiers, artworks, and PILsSupport COPP applications for registrations in other marketsQualifications & ExperienceBachelor’s or Master’s degree in Pharmacy10+ years of Regulatory Affairs experience in Saudi Arabia pharma industryStrong hands-on experience with SFDA regulations and submissionsPeople management experience preferredFluent in English; Arabic proficiency strongly preferredKey SkillsSFDA regulatory expertiseStrategic regulatory planningStakeholder & authority liaisonDossier review & complianceStrong communication and leadership skills#J-18808-Ljbffr