Senior Regulatory Affairs Specialist

iqvia; Paris; On-site; EUR 60,000 - 85,000; Full time

Job summary

IQVIA is seeking a Senior Regulatory Affairs Specialist to lead country-level regulatory activities for medicinal products in France. You will prepare submissions, manage lifecycle activities, and maintain compliant regulatory records across a diverse portfolio.

You will collaborate with Medical Affairs, Quality, Commercial and Global Regulatory teams to drive approvals and ensure high-quality outcomes for patients and healthcare systems. French and English fluency required.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field.
• Significant regulatory affairs experience in pharma, including post-approval activities.
• Knowledge of local regulatory requirements and submission procedures.
• Experience lifecycle management: variations, renewals, labeling updates, MAH transfers.
• Experience reviewing promotional materials for France per codes.
• Strong multitasking, attention to detail, and stakeholder management.
• Fluent in French and English; able to work with global teams.

Responsibilities

• Lead country-level regulatory activities for medicinal products in France.
• Prepare, coordinate, and submit regulatory documentation for lifecycle activities.
• Act as regulatory contact for clients and Health Authorities; drive submissions to approval.
• Support end-to-end lifecycle management and maintain compliant regulatory records.
• Review and approve promotional/non-promotional materials in France.
• Review artwork, labeling updates, and packaging components for consistency.
• Monitor changes in local regulation and advise on actions.
• Collaborate with Medical Affairs, Quality, Commercial, and Global Regulatory teams.
• Contribute to process improvements and share regulatory knowledge.

Skills

Stakeholder management

Communication skills

Problem-solving

French language

English language

MS Office

Regulatory systems

Education

Bachelor's degree in Pharmacy or Life Sciences

Tools

Artwork review tools

Regulatory information management systems

Job 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.

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 Managementactivities, 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.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.