Senior Clinical Regulatory Affairs Manager

RBW Consulting; France; À distance; EUR 80 000 - 100 000; Plein temps

Résumé du poste

A global CRO specializing in oncology research is seeking a Senior Regulatory Affairs Manager to lead regulatory activities across Europe. The suitable candidate should have over 5 years' experience in regulatory affairs, particularly in clinical trials, with hands-on knowledge of CTA submissions. This fully remote position is a vital role in shaping the future of oncology trials in various EU countries.

Qualifications

• 5+ years in regulatory affairs within clinical trials.
• Experience with CTIS and IRAS CTA preparations and submissions.
• Knowledge of ICH-GCP and EU/UK regulatory frameworks.

Responsabilités

• Lead CTA submissions and regulatory strategies across EU/UK.
• Serve as the regulatory liaison for multi-continental oncology trials.
• Stay ahead of evolving EU/UK regulations and provide expert guidance.

Connaissances

Regulatory Knowledge

Communication Skills

Problem-Solving Skills

Description du poste

Senior Regulatory Affairs Manager (Remote - EU/UK)

Are you a regulatory expert with a passion for oncology clinical trials? Join a global CRO with over 40 years of experience in advancing cancer research.

We’re looking for aSenior Regulatory Affairs Managerto lead and support regulatory activities across Europe. This fully remote role is open to candidates based in theUK, France, Italy, Spain, Sweden, or Ireland.

What You’ll Do:

• Lead CTA submissions and regulatory strategies across EU/UK
• Serve as the regulatory liaison for multi-continental oncology trials
• Collaborate cross-functionally with Clinical Ops, Medical Writing, QA, and more
• Stay ahead of evolving EU/UK regulations and provide expert guidance

What You’ll Bring:

• 5+ years in regulatory affairs within clinical trials (CRO experience preferred)
• Hands-on experience with CTIS and IRAS CTA preparations and submissions
• Strong knowledge of ICH-GCP and EU/UK regulatory frameworks
• Excellent communication, organization, and problem-solving skills Fluent English required

Ready to make a difference in cancer research? Apply now and help shape the future of oncology trials.