Help bring regulatory submissions from planning to successful delivery

At IQVIA, our Regulatory Affairs teams support the development and lifecycle management of medicines across global markets. We are looking for a Regulatory Affairs Specialist to join our team and support the planning, coordination and delivery of EU regulatory submissions.

In this role, you will manage submission activities from planning through delivery, working closely with Regulatory Affairs colleagues, publishing teams, clients and cross-functional stakeholders. You will bring strong organizational skills, regulatory submission experience and attention to detail to help ensure high-quality documentation is delivered accurately and on time.

This is an opportunity to work independently, take ownership of submission activities and collaborate with colleagues and clients in an international regulatory environment.

• Plan, coordinate and track EU regulatory submissions against project requirements and agreed timelines.
• Prepare, review and coordinate Module 1 documentation and CTD/eCTD submission packages.
• Partner with Regulatory Affairs, publishing and cross-functional teams to confirm submission readiness and resolve documentation gaps.
• Maintain submission plans, trackers and supporting documentation, ensuring accurate and up-to-date information.
• Coordinate submission content and timelines with document owners and project stakeholders.
• Support lifecycle management activities, including variations, renewals and other post-approval submissions, as applicable.
• Keep internal teams and clients informed of submission progress, risks, dependencies and required actions.
• Build effective working relationships with clients, project teams and other key stakeholders.
• Manage your workload independently while ensuring deliverables meet project requirements and timelines.
• Ensure regulatory activities are completed in accordance with applicable regulations, guidelines and standard operating procedures.
• Contribute to continuous improvement and share regulatory knowledge with colleagues, including providing guidance to junior team members where appropriate.

Desired Candidate Profile

• Bachelor s degree in Life Sciences, Pharmacy or another relevant scientific discipline. A master s degree would be an advantage.
• At least 3 4 years of relevant Regulatory Affairs experience.
• Hands-on experience coordinating regulatory submissions, ideally within an EU regulatory environment.
• Experience preparing or coordinating Module 1 documentation and CTD/eCTD submission packages.
• Good understanding of regulatory submission processes and lifecycle management activities.
• Knowledge of relevant regulatory requirements, guidelines and standard operating procedures.
• Experience with regulatory publishing or document management systems. Veeva Vault experience would be an advantage.
• Strong planning and organizational skills, with the ability to manage multiple activities and deadlines independently.
• Excellent attention to detail and the ability to identify and follow up on submission-related issues.
• Strong communication and stakeholder-management skills, with confidence working across internal teams and with clients.
• Strong written and verbal communication skills in English.
• Proficiency in Microsoft Office and relevant regulatory systems.
• Flexibility and the ability to adapt to changing project priorities and requirements.