EU CTR Submissions Lead & CTIS Expert

Biogen, Inc.; Baar; On-site; CHF 140,000 - 190,000; Full time

Job summary

Biogen in Switzerland seeks an EU CTR Submission Lead to drive the full lifecycle of regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. You will provide strategic submission planning, cross-functional coordination, and SME guidance to ensure timely, compliant submissions across the EU/EEA.

This senior role emphasizes mentorship, complex program oversight, and collaboration with Regulatory Affairs, Clinical Trial Delivery, and Safety, while upholding EMA guidance and

Qualifications

• Bachelor’s or Master’s in Life Sciences or related field.
• 5+ years’ experience with EU CTR submissions and CTIS.
• Strong understanding of EU CTR timelines, dossier content, and results reporting.
• Proven ability to lead complex submission programs.
• Excellent communication, prioritization, and problem-solving skills.

Responsibilities

• Lead planning and execution of initial CTAs, Part I & II submissions, and CTIS lifecycle activities.
• Oversee RFIs and ensure high-quality, timely responses.
• Provide SME guidance for End-of-Study activities (EoT), CSR and CSRr submissions.
• Ensure submissions comply with EU CTR 536/2014, ICH-GCP, EMA guidance, and SOPs.
• Mentor team members and train stakeholders on CTIS functionalities and updates.

Skills

Regulatory submissions

CTIS expertise

Cross-functional leadership

Regulatory strategy

Problem-solving

Communication

Education

Bachelor’s or Master’s in Life Sciences

Tools

CTIS System

Job description

Biogen in Switzerland seeks an EU CTR Submission Lead to drive the full lifecycle of regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. You will provide strategic submission planning, cross-functional coordination, and SME guidance to ensure timely, compliant submissions across the EU/EEA.

This senior role emphasizes mentorship, complex program oversight, and collaboration with Regulatory Affairs, Clinical Trial Delivery, and Safety, while upholding EMA guidance and