Senior Regulatory Affairs Specialist

JR France; Lyon; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading regulatory solutions provider in Lyon seeks a Senior Regulatory Affairs Specialist with 5 to 8 years of experience. The role involves developing global regulatory strategies, managing submissions, and collaborating with cross-functional teams. Candidates must be located in France, the EU, or the UK, and an EU work permit is required. Join us to redefine regulatory excellence in a collaborative environment.

Qualifications

• 5 to 8 years of experience in Regulatory Affairs.
• Proficient in regulatory submissions and lifecycle management.

Responsabilités

• Develop global regulatory strategies and manage lifecycle activities.
• Coordinate CTA activities with multidisciplinary teams.
• Research regulatory intelligence to navigate complex requirements.

Connaissances

EU CTR

CTIS

CTA

Outils

Document Management Systems

Microsoft Office Suite

SharePoint

Description du poste

Job Description: Senior Regulatory Affairs Specialist, Lyon

Location: Lyon, France / EU / UK

Experience: 5 to 8 years in Regulatory Affairs

Key Skills: Hands-on EU CTR, CTIS, CTA experience in Medicinal Products

Responsibilities:

1. Provide critical support in developing global regulatory strategies, planning, and execution of investigational submissions, and managing lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
2. Collaborate with the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans and address regulatory issues, health authority queries, and obligations.
3. Research and apply regulatory intelligence to navigate complex global requirements and develop innovative regulatory pathways.
4. Perform independent QC on CTA submissions, including documents and data within CTIS and IRAS portals.
5. Coordinate CTA activities with multidisciplinary teams as a liaison.
6. Support the preparation, submission, lifecycle management, and archiving of CTA submissions and correspondence.
7. Develop regulatory operations work instructions and stay updated on regulatory standards.
8. Maintain knowledge of EU Clinical Trial Regulation (CTR) and UK Medicines for Human Use (CTs) regulations.
9. Manage and produce time-sensitive deliverables with attention to detail.
10. Utilize Document Management Systems (preferably Documentum) and experience with regulatory submissions via Health Authority Portals.
11. Proficient in Microsoft Office Suite and SharePoint; experience with regulatory applications like CTAs is preferred.

Additional Information:

Applications are only considered from candidates located in France, EU, or UK. EU work permit is required. Not for candidates located in India. Applications from other locations will not be considered.

About Freyr: Freyr Solutions is a fast-growing company providing regulatory solutions for the Life Sciences industry, fostering a collaborative and innovative work environment. Join us to shape the future of regulatory services.

To Apply: Please apply directly to this job post or visit our Careers page for more opportunities. Explore current openings and submit your application to be part of Freyr's expansion and redefine regulatory excellence.