Senior Regulatory Affairs Specialist

About the role

As a Senior Regulatory Affairs Specialist at IQVIA, you will shape regulatory excellence and support the full product lifecycle of a diverse portfolio of medicinal products. You will work with global pharmaceutical companies, provide regulatory expertise and help deliver high-quality outcomes for patients and healthcare systems. This is a fixed-term contract of 12 months with the possibility of conversion to a permanent contract.

Key responsibilities

• Lead and manage country-level regulatory activities for medicinal products, ensuring compliance with local requirements.
• Prepare, coordinate and submit regulatory documentation for lifecycle activities such as variations, renewals, notifications, line extensions, MAH transfers and new marketing authorisation applications.
• Act as a key regulatory contact for clients and Health Authorities, guiding them and driving submissions to approval.
• Support end-to-end Lifecycle Management, keeping product information and regulatory records compliant and up to date.
• Review and approve promotional and non-promotional materials in France, and artwork, labelling updates and packaging components, against local regulations, company policy and industry codes.
• Monitor changes in local legislation, assess their business impact and implement required actions.
• Collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams, and contribute to process improvement.

Required profile

• Bachelor's degree in Pharmacy, Life Sciences or a related scientific discipline.
• Significant experience in Regulatory Affairs in the pharmaceutical industry, including post-approval activities and product lifecycle maintenance.
• Experience reviewing and approving promotional and non-promotional materials in France.
• Fluent written and spoken French and English.
• Ability to manage several projects at once with accuracy and attention to detail.

Required skills

• Strong knowledge of local pharmaceutical legislation, regulatory requirements and submission procedures.
• Experience with Lifecycle Management activities (variations, renewals, labelling updates, marketing authorisations).
• Advanced computer skills, including MS Office; experience with regulatory information management systems and artwork review tools is an advantage.