Senior Regulatory Affairs Specialist

IQVIA; Paris; Presencial; EUR 70.000 - 105.000; Jornada completa

Descripción de la vacante

IQVIA in Paris is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for medicinal products and lifecycle management, ensuring compliance across the portfolio.

You will prepare and submit documentation, act as the primary regulatory contact with Health Authorities, review labeling and artwork, and collaborate with Medical Affairs, Quality, Commercial, and Global Regulatory teams to drive excellence.

Formación

• 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, 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 high accuracy and attention to detail.

Responsabilidades

• 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, labeling 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.

Conocimientos

Regulatory affairs

Lifecycle management

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Bilingual FR/EN

Educación

Bachelor's degree in Pharmacy, Life Sciences, or related

Herramientas

Regulatory information management systems

Artwork review tools

MS Office

Descripción del empleo

Paris, France

Full time

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 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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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