Regulatory Affairs Senior Specialist - Submission Manager

Join IQVIA as a Submission Manager, Regulatory Affairs and take ownership of global regulatory submission activities across the product lifecycle, from First-in-Human through to license withdrawal.

In this client-facing role, you’ll work closely with Global Regulatory Leads and cross-functional teams to plan and deliver high-quality regulatory submissions across multiple markets. You’ll combine your regulatory expertise with strong project management and stakeholder skills to keep complex submission activities moving forward.

This is an excellent opportunity for an experienced Regulatory Affairs professional who enjoys taking ownership, coordinating globally and working directly with clients and senior regulatory stakeholders.

• →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, proactively identify risks and support timely resolution of issues.
• →Provide clear updates on submission status, priorities and risks to clients and internal stakeholders.
• →Support lifecycle activities, including dossier maintenance, health authority responses and regulatory information management.
• →Build strong relationships with client stakeholders and act as a trusted partner throughout submission delivery.

• 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.
• Practical knowledge of eCTD and electronic regulatory submission processes.
• EU and/or US submission experience is strongly preferred.
• Experience using Veeva or similar regulatory systems.
• Strong project management skills, with the ability to manage multiple timelines, deliverables and stakeholders.
• Confidence working directly with clients and communicating with global and cross-functional teams.
• Strong attention to detail and commitment to quality.
• Excellent written and verbal communication skills in English.

At IQVIA, you’ll work at the intersection of science, technology and healthcare, collaborating with experienced regulatory professionals and clients across global drug development programs.

You’ll have the opportunity to take meaningful ownership of complex submission activities, build your international regulatory experience and contribute to programs that help bring new therapies to patients.

If you’re an experienced Regulatory Affairs professional who enjoys turning complex submission requirements into clear plans and successful delivery, we’d like to hear from you.

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.