Senior Regulatory Affairs Specialist

IQVIA; Paris; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

IQVIA in Paris seeks a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products, ensuring compliance with local requirements and lifecycle management. You will prepare and submit documentation for variations, renewals, and new marketing authorizations, acting as a main regulatory contact for clients and health authorities.

You will support end-to-end lifecycle maintenance, review promotional materials, monitor regulatory changes, and collaborate

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or a related scientific discipline.
• Significant experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of local pharmaceutical legislation, regulatory requirements, and submission procedures.
• Experience in Lifecycle Management activities, including variations, renewals, labeling 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 with accuracy and attention to detail.
• Strong stakeholder management, communication, and problem-solving skills.
• Fluent written and verbal communication in French and English.
• Advanced computer skills; experience with regulatory information management systems and artwork review tools is an advantage.

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 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 and industry codes.
• Review and approve artwork, labeling updates, and packaging components, ensuring consistency with approved product information.
• Monitor changes in local regulatory legislation and advise on business impact; implement required actions.
• Collaborate with Medical Affairs, Quality, Commercial, and Global Regulatory teams to support business objectives and regulatory excellence.
• Contribute to process improvements and share regulatory expertise with internal stakeholders and clients.

Skills

Regulatory expertise

Stakeholder management

Communication

Problem solving

Project management

Attention to detail

Team collaboration

Education

Bachelor's degree (Pharmacy/Life Sciences)

Tools

MS Office

Regulatory information management systems

Artwork review tools

Job description

## Senior Regulatory Affairs SpecialistApplylocations: Paris, Francetime type: Full timeposted on: Posted Todayjob requisition id: R1556847**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 Managementactivities, 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.comIQVIA 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.