Description
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.
Responsibilities
- 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.
Requirements
- 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.