France Regulatory Affairs Lead: Lifecycle & Submissions

IQVIA; Paris; In loco; EUR 70.000 - 105.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory affairs

Lifecycle management

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Bilingual FR/EN

Formazione

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

Strumenti

Regulatory information management systems

Artwork review tools

MS Office

Descrizione del lavoro

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.