Lead planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities.
Oversee preparation and submission of Requests for Information (RFIs), ensuring high-quality and timely responses.
Provide subject matter expertise for end-of-study activities, including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions.
Conduct quality oversight and ensure alignment with EU CTR, EMA guidance, and internal standards operating procedures.
Strategic & Cross-Functional Leadership
Serve as SME for EU CTR and CTIS processes, interpreting regulatory expectations.
Lead submission readiness activities and coordinate with internal stakeholders (Regulatory Affairs, Clinical Trial Delivery and Clinical Trial Acceleration Units, Country & site Operations and Safety).
Lead EU CTR Study Submission Team meetings to align submission strategy and timelines.
Compliance & Quality Oversight
Ensure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.
Support audits and inspections related to submission activities.
Contribute to development and maintenance of SOPs, work instructions, and templates.
CTIS System Expertise
Lead complex CTIS activities: dossier creation, document upload, metadata accuracy, lifecycle management, public disclosure settings.
Troubleshoot system issues and liaise with EMA as needed.
Train project teams and stakeholders on CTIS functionalities and updates.
Qualifications & Experience
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.
Core Competencies & Skills
Strategic thinking
Cross-functional leadership
Problem-solving and analytical skills
High attention to detail
Excellent communication
Please note that this role requires a candidate to be a holder of work permit & residency in Poland.
About Biogen Poland
About Global Business Services (GBS)
#LI-Hybrid
Job Level: Professional
Additional Information
The base compensation range for this role is: zł184,000.00-zł246,250.00
Benefits
Competitive Total Rewards: Base salary is determined by your experience, skills, and internal equity, complemented by an annual bonus to recognize your performance and contributions.Comprehensive Benefits for You and Your Family: Includes life insurance, pension program contributionsEquity / stock optionsPerformance bonus
Additional Information
About this role
The EU CTR Submission Lead is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted under the EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role provides strategic submission planning, cross-functional coordination, and subject matter expertise (SME) while ensuring timely, high-quality control, and compliant submissions across the EU/EEA. The Submission Lead is a senior technical leadership role, who plays a pivotal role in mentoring junior team members without direct line management responsibilities.
Biogen · Warsaw, Poland