Senior Regulatory Affairs Specialist

Shape the future of regulatory excellence at IQVIA

At IQVIA, we work to advance healthcare by helping our clients bring safe, effective medicines to patients. As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the full product lifecycle across a diverse portfolio of medicinal products. You will collaborate with leading global pharmaceutical companies, provide regulatory expertise, and contribute to high-quality outcomes that make a real difference to patients and healthcare systems. This is a fixed-term opportunity for 12 months contract.

What you will do

• Lead and manage country-level regulatory activities for medicinal products, ensuring compliance with local regulatory requirements.
• Prepare, coordinate, and submit regulatory documentation for lifecycle management activities, including variations, renewals, notifications, line extensions, MAH transfers, and new marketing authorization applications.
• Act as a key regulatory contact for clients and Health Authorities, providing strategic guidance and driving submissions through successful approval.
• Support end-to-end Lifecycle Management activities, ensuring product information and regulatory records remain compliant and up to date.
• Review and approve promotional and non-promotional materials in France to ensure compliance with local regulatory requirements, company policies, and applicable industry codes.
• Review and approve artwork, labelling updates, and packaging components, ensuring consistency with approved product information.
• Monitor changes in local regulatory legislation and assess business impact, providing recommendations and implementing required actions.
• Collaborate closely with cross-functional teams, including Medical Affairs, Quality, Commercial, and Global Regulatory teams, to support business objectives and regulatory excellence.
• Contribute to process improvement initiatives and share regulatory expertise with internal stakeholders and clients.

What you need to succeed

• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Significant experience in Regulatory Affairs within the pharmaceutical industry, including management of post-approval regulatory activities and product lifecycle maintenance.
• Strong knowledge of local pharmaceutical legislation, regulatory requirements, and submission procedures.
• Experience in Lifecycle Management activities, including variations, renewals, labelling updates, and maintenance of marketing authorizations.
• Experience reviewing and approving promotional and non-promotional materials in France in accordance with applicable regulatory requirements and industry codes.
• Proven ability to manage multiple projects simultaneously while maintaining a high level of accuracy and attention to detail.