Senior Regulatory Affairs Specialist

JR France; Saint-Nazaire; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading company in regulatory solutions is seeking a Senior Regulatory Affairs Specialist in France. The role involves developing regulatory strategies, collaborating with teams, and ensuring compliance with EU regulations. Candidates should have 5-8 years of experience and expertise in EU CTR and CTIS. Join a dynamic team dedicated to regulatory excellence and innovation.

Qualifications

• 5 to 8 years in Regulatory Affairs.

Responsabilités

• Develop global regulatory strategies and manage lifecycle activities.
• Collaborate with the global regulatory team on regulatory issues.
• Research regulatory intelligence for innovative pathways.

Connaissances

Hands-on EU CTR

CTIS

CTA experience in Medicinal Products

Outils

Microsoft Office

SharePoint

Description du poste

Job Description

This position is not for candidates located in India. Applications from locations other than France, EU, or UK will not be considered.

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance complexities.

Why Freyr?

We foster a collaborative, dynamic work environment that empowers our team. As we expand, we seek passionate regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team

If you're ready for growth and innovation, explore exciting opportunities with Freyr. Together, we can redefine regulatory excellence.

How to Apply

Please apply through this job post or visit our Careers page for more openings.

Visit our Careers page to explore current openings and submit your application.

Position Details

• Title: Senior Regulatory Affairs Specialist
• Location: France / EU / UK
• Experience: 5 to 8 years in Regulatory Affairs
• Key Skills: Hands-on EU CTR, CTIS, CTA experience in Medicinal Products

Responsibilities

• Develop global regulatory strategies and manage lifecycle activities in alignment with the Global Regulatory Lead (GRL).
• Collaborate with the global regulatory team to address regulatory issues, health authority queries, and obligations.
• Research regulatory intelligence and apply strategic options for innovative pathways.
• Perform QC on CTA submissions, including documents and data in CTIS and IRAS portals.
• Coordinate CTA activities with multidisciplinary teams.
• Support preparation, submission, and archival of CTA documents and correspondences.
• Develop regulatory operations work instructions.
• Stay updated with regulatory standards and guidance, especially EU CTR and UK regulations.
• Manage and produce time-sensitive deliverables with attention to detail.
• Utilize Document Management Systems and submit regulatory applications via Health Authority Portals.
• Proficient in Microsoft Office and SharePoint.