EU CTR Submissions Lead & CTIS Strategy Expert

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

Job summary

Biogen is seeking an EU CTR Submission Lead to oversee the full lifecycle of regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. The role provides strategic planning, cross-functional coordination, and SME guidance while ensuring compliant, timely submissions across the EU/EEA.

The position is senior-level, mentoring teammates and coordinating with Regulatory Affairs, Clinical Trial Delivery, and Safety to meet submission timelines and quality standards.

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.
• Experience in pharma, biotech, or CRO.
• Excellent communication, prioritization, and problem-solving skills.

Responsibilities

• Lead planning and execution of Initial CTAs and CTIS lifecycle activities.
• Oversee preparation and submission of Requests for Information (RFIs).
• Provide SME for end-of-study activities including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions.
• Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.

Skills

Regulatory strategy

Cross-functional leadership

Project management

CTIS expertise

EU CTR submissions

Communication skills

Education

Bachelor or Master in Life Sciences

Tools

CTIS platform

eCTD

Job description

Biogen is seeking an EU CTR Submission Lead to oversee the full lifecycle of regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. The role provides strategic planning, cross-functional coordination, and SME guidance while ensuring compliant, timely submissions across the EU/EEA.

The position is senior-level, mentoring teammates and coordinating with Regulatory Affairs, Clinical Trial Delivery, and Safety to meet submission timelines and quality standards.