Senior EU CTR Submissions Lead — CTIS Expert

Biogen; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Life insurance

Remote work allowance

Flexible work arrangements

Professional development funding

Employee referral bonuses

Social activities

Job summary

Biogen Poland seeks an EU CTR Submission Lead to steer regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. You will provide strategic planning, cross-functional coordination, and SME guidance to ensure timely, high-quality EU/EEA submissions.

This senior role mentors junior team members and collaborates with Regulatory Affairs, Clinical Trial Delivery, and Operations to drive submission readiness and ensure compliance with EU regulatory expectations.

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 CTAs, Part I & II submissions, SMs, and CTIS lifecycle activities.
• Oversee preparation and submission of RFIs with high quality and timely responses.
• Provide SME for end-of-study activities including EoT, Summary of Results, Lay Summary, CSR and CSRr submissions.
• Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and internal SOPs.
• Lead EU CTR Study Submission Team meetings to align strategy and timelines.
• Train project teams on CTIS functionalities and updates.

Skills

Regulatory submissions

CTIS expertise

Cross-functional leadership

Regulatory strategy

Communication

Education

Life Sciences degree

Tools

CTIS

Job description

Biogen Poland seeks an EU CTR Submission Lead to steer regulatory submissions for clinical trials under EU CTR 536/2014 via CTIS. You will provide strategic planning, cross-functional coordination, and SME guidance to ensure timely, high-quality EU/EEA submissions.

This senior role mentors junior team members and collaborates with Regulatory Affairs, Clinical Trial Delivery, and Operations to drive submission readiness and ensure compliance with EU regulatory expectations.