Regulatory Affairs Senior Specialist - Submission Manager

About the role

IQVIA is hiring a Submission Manager in Regulatory Affairs in New Cairo. The role takes ownership of global regulatory submission activities across the product lifecycle, from First-in-Human through to license withdrawal. It is client-facing, working closely with Global Regulatory Leads and cross-functional teams to plan and deliver high-quality submissions across multiple markets.

Key responsibilities

• Lead the planning, coordination and delivery of global regulatory submissions across the product lifecycle.
• Develop and manage submission plans, timelines, milestones and dependencies.
• Coordinate dossier preparation and compilation, including reference dossiers and eCTD structures.
• Partner with global, regional and local Regulatory Affairs teams to adapt and deliver dossiers for different markets.
• Coordinate inputs across Regulatory CMC, Medical Writing, Clinical Development, publishing teams and external partners.
• Monitor submission progress, identify risks early and support timely resolution of issues.
• Provide clear updates on submission status, priorities and risks to clients and internal stakeholders.
• Support lifecycle activities such as dossier maintenance, health authority responses and regulatory information management.
• Build strong relationships with client stakeholders and act as a trusted partner throughout submission delivery.

Required profile

• Degree in Life Sciences or a related discipline.
• Approximately 4+ years of experience in Regulatory Affairs, regulatory submissions or a related pharmaceutical/drug development environment.
• Hands-on experience coordinating or leading regulatory submissions for clinical trial and/or marketing authorization activities.
• EU and/or US submission experience is strongly preferred.
• Experience using Veeva or similar regulatory systems.
• Strong project management skills, confidence working with clients and communicating with global, cross-functional teams.
• Excellent written and verbal communication skills in English.