Senior Regulatory Affairs Specialist

JR France; Asnières-sur-Seine; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading company is seeking a Senior Regulatory Affairs Specialist to provide critical support in developing global regulatory strategies and managing lifecycle regulatory activities. The role involves collaboration with various teams and requires hands-on experience with EU CTR, CTIS, and CTA in Medicinal Products. Candidates should have 5 to 8 years of relevant experience and must possess an EU work permit.

Qualifications

• 5 to 8 years in Regulatory Affairs.
• Experience in submitting regulatory documents via Health Authority Portals.

Responsabilités

• Support in developing global regulatory strategies and submissions.
• Coordinate CTA activities with multidisciplinary teams.
• Stay updated with regulatory and industry standards.

Connaissances

EU CTR

CTIS

CTA

Medicinal Products

Outils

Document Management Systems

Microsoft Office Suite

SharePoint

Description du poste

Job 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

Job Description:

1. Provide critical support in developing global regulatory strategies, planning, and execution of global investigational submissions, and managing lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
2. Work collaboratively with the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations.
3. Research and apply regulatory intelligence and knowledge of strategic options to effect innovative regulatory pathways and solutions to complex global requirements and regulatory challenges.
4. Perform independent QC on prepared CTA submissions, including submission documents and structured 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. Assist in developing regulatory operations work instructions.
8. Stay updated with regulatory and industry standards.
9. Maintain overall knowledge of EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019.
10. Manage and produce time-sensitive deliverables efficiently.
11. Ensure accuracy in data entry and adherence to procedural steps.
12. Utilize Document Management Systems (preferably Documentum-based).
13. Experience in submitting regulatory documents via Health Authority Portals.
14. Proficient in Microsoft Office Suite and SharePoint.
15. Experience with regulatory applications such as CTAs is preferred.

Note: Applications from India are not considered. Candidates must have EU work permit.