Requirements
The ideal candidate will have a Bachelor's degree in Pharmacy, Life Sciences, or a related discipline, with at least 6 years of Regulatory Affairs experience in the pharmaceutical, biotechnology, or healthcare industry. Proven experience supporting Saudi Arabia and GCC regulatory activities, including lifecycle management, regulatory submissions, and health authority interactions, is essential. Strong project management, client management, and stakeholder management skills are required, along with knowledge of CTD/eCTD dossier preparation and maintenance.
Description
Join IQVIA and help bring innovative healthcare products to patients across Saudi Arabia and the GCC.IQVIA is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and execution across Saudi Arabia and the wider GCC region. This is an exciting opportunity for a regulatory professional who enjoys working directly with clients, navigating complex regulatory environments, and leading high-impact projects from planning through delivery.Working as part of IQVIA's growing Regulatory Affairs team, you will partner with pharmaceutical and biotechnology clients to support market authorization activities, lifecycle management programs, regulatory submissions, and interactions with regional health authorities. The role offers significant ownership, client exposure, and the opportunity to contribute to strategic regulatory initiatives across multiple markets.What You'll DoLead regulatory projects across Saudi Arabia and GCC marketsManage market authorization applications, transfers and lifecycle management activitiesPrepare, review and oversee CTD/eCTD submissionsCoordinate regulatory variations, labeling updates and post-approval maintenance activitiesServe as a key point of contact for health authorities, clients and internal stakeholdersMonitor regulatory intelligence and assess the impact of regulatory changes Develop regulatory strategies aligned with client and business objectives Manage timelines, risks and project deliverablesSupport business growth activities, client presentations and proposal developmentMentor and support less experienced team membersWhat We're Looking ForBachelor's degree in Pharmacy, Life Sciences or a related disciplineAt least 6 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or healthcare industryStrong experience supporting Saudi Arabia and GCC regulatory activitiesHands-on experience with lifecycle management, regulatory submissions and health authority interactionsKnowledge of CTD/eCTD dossier preparation and maintenanceStrong project management and stakeholder management skillsExperience working directly with clients and managing multiple prioritiesFluent English and ArabicNice to HaveExperience supporting biologics, vaccines or specialty productsExperience working directly with SFDA and other GCC health authoritiesAdditional language skills such as French or SpanishExperience leading projects or managing client portfoliosIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.