Strategic EU CTR Submissions Lead (CTIS)

Biogen, Inc.; Warszawa; On-site; PLN 250,000 - 320,000; Full time

Benefits offered by this job

Remote work allowance

Life insurance

Pension contributions

Flexible work arrangements

Professional development funding

Job summary

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

You will mentor junior team members in a senior technical leadership role, with no direct line management responsibilities, and collaborate with Regulatory Affairs, Clinical Trial Delivery, and

Qualifications

• Bachelor’s or Master’s in Life Sciences or related field.
• 5+ years’ experience with EU CTR submissions and advanced CTIS expertise.
• 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.
• Experience in pharma, biotech, or CRO.
• Knowledge of regulatory intelligence and EU regulatory strategy.

Responsibilities

• Regulatory Submission Leadership: Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities. Oversee RFIs and ensure timely responses.
• Strategic & Cross-Functional Leadership: SME for EU CTR and CTIS processes; coordinate with Regulatory Affairs, Clinical Trial Delivery and Acceleration Units, Country & site Operations and Safety.
• Compliance & Quality Oversight: Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance; support audits and inspections; contribute to SOPs and templates.
• CTIS System Expertise: Lead complex CTIS activities: dossier creation, upload, metadata accuracy, lifecycle management; train teams on CTIS functionalities.

Skills

EU CTIS expertise

Regulatory submissions

Cross-functional leadership

Strategic planning

Regulatory strategy

Education

Bachelor’s or Master’s in Life Sciences

Tools

CTIS platform

Job description

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

You will mentor junior team members in a senior technical leadership role, with no direct line management responsibilities, and collaborate with Regulatory Affairs, Clinical Trial Delivery, and