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.

Key Responsibilities

1. Regulatory Submission Leadership

• 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.

2. 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.

3. 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.

4. 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

Our Warsaw office is a complex hub for local, regional and global roles. Regardless our role and reporting line we’re driven every day by our unique purpose, working passionately to change the lives of patients affected by rare and devastating diseases. This is what gives us pride, inspires us and gives us fuel to push the boundaries of innovation. We represent over 30 nationalities and celebrate the strength that comes from differences in backgrounds, experiences, and perspectives. This commitment to fostering a supportive and inclusive workplace earned us a Great Place to Work Certificate and Best Places to Work Awards consecutively since 2021 in Poland and Europe. If our mission resonates with your heart and career aspirations, we’re inviting you to join our team.

About Global Business Services (GBS)

The Global Business Services (GBS) team transforms Biogen’s business processes, scaling global operations and fueling commercial growth and innovation. GBS adds value by delivering business solutions and support services through a global delivery model, operational transparency, and best practices. Aiming to be a world-class organization, GBS excels in people, solutions, execution, and partnerships, championing a continuous improvement culture recognized across Biogen. We form a great team of individuals with drive for innovation but also team players collaborating in the spirit of respect. And if you want to take your professional development in your own hands, this is a place for you. We give you a lot of opportunities for growth on a business and social ground.

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