Senior Regulatory Affairs Specialist
IQVIA · Paris
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 with possibility to convert into permanent 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.
- Strong stakeholder management, communication, and problem-solving skills.
- Ability to work independently while collaborating effectively within global and local teams.
- Fluent written and verbal communication skills in both French and English.
- Advanced computer skills, including MS Office; experience with regulatory information management systems and artwork review tools is an advantage.
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.