Regulatory Affairs Manager

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 Do

• Lead regulatory projects across Saudi Arabia and GCC markets

• Manage market authorization applications, transfers and lifecycle management activities

• Prepare, review and oversee CTD/eCTD submissions

• Coordinate regulatory variations, labeling updates and post-approval maintenance activities

• Serve as a key point of contact for health authorities, clients and internal stakeholders

• Monitor regulatory intelligence and assess the impact of regulatory changes Develop regulatory strategies aligned with client and business objectives Manage timelines, risks and project deliverables

• Support business growth activities, client presentations and proposal development

• Mentor and support less experienced team members

What We're Looking For

• Bachelor's degree in Pharmacy, Life Sciences or a related discipline

• At least 6 years of Regulatory Affairs experience within the pharmaceutical, biotechnology or healthcare industry

• Strong experience supporting Saudi Arabia and GCC regulatory activities

• Hands-on experience with lifecycle management, regulatory submissions and health authority interactions

• Knowledge of CTD/eCTD dossier preparation and maintenance

• Strong project management and stakeholder management skills

• Experience working directly with clients and managing multiple priorities

• Fluent English and Arabic

Nice to Have

• Experience supporting biologics, vaccines or specialty products

• Experience working directly with SFDA and other GCC health authorities

• Additional language skills such as French or Spanish

• Experience leading projects or managing client portfolios

IQVIA 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.com

IQVIA 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.