EU CTR Submission Specialist

Position Summary

The EU CTR Submission Specialist is responsible for planning, preparing, managing, and maintaining regulatory submissions for clinical trials in compliance with EU Clinical Trial Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This role covers the entire lifecycle of a clinical trial, from initial application through substantial modifications to end-of-study reporting and public disclosure deliverables.

Key Responsibilities

1. Regulatory Submission Management

• Prepare, compile, and submit Initial Clinical Trial Applications (CTAs) in CTIS in line with EU CTR requirements.

• Coordinate and submit Part I and Part II documentation, ensuring compliance, accuracy, and consistency across EU/EEA Member States.

• Manage Substantial Modifications (SMs), safety notifications, administrative changes, and ongoing trial maintenance activities.

• Prepare, coordinate, and submit Requests for Information (RFIs) within mandated timelines.

• Execute all end-of-study regulatory activities, including End-of-Study (EoS) Notifications, submission of the Summary of Results and Clinical Study Report (CSR).

• Ensure all EU CTR–mandated reporting deadlines are met.

• Maintain accurate documentation in CTIS and internal tracking systems throughout the trial lifecycle.

• Monitor submission status and ensure proper lifecycle management.

2. Cross-Functional Collaboration

• Partner with Regulatory Affairs, Clinical Trial Acceleration and Clinical Trial Delivery units as well as Country and site operations.

• Provide guidance on CTIS processes and EU CTR obligations.

• Participate in EU CTR Study Submission Team meetings to align submission strategy and timelines.

3. Compliance & Quality Oversight

• Ensure compliance with EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.

• Maintain awareness of CTIS updates and evolving regulatory expectations.

• Support inspections and audits.

• Ensure documentation quality, SOP adherence, and consistency.

4. CTIS System Expertise

• Manage operational tasks in CTIS including roles, dossier creation, uploads, and lifecycle management.

• Manage public disclosure settings and support redaction workflows.

• Troubleshoot CTIS issues and train internal teams.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related discipline.

• 1–3+ years of experience in EU clinical trial submissions or regulatory operations.

• Hands-on CTIS experience.

• Strong organizational and communication skills.

• Proficiency in English.

• Experience in pharmaceutical, biotech, or CRO environment.

• Proficiency with Microsoft Office applications and electronic document management systems. 

Core Competencies & Skills

• Strong organizational skills, attention to detail, and ability to multitask effectively. 

• Analytical and problem-solving skills, effective communication and can-do attitude

• Adaptability and ability to work under deadlines

• Understanding of regulatory frameworks

Additional information

• The base compensation range per year for this role is: 162 000 - 216 750 PLN gross. 
• This role is in hybrid model of work.
• 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.

 #LI-Hybrid

 

Job Level: Professional

Additional Information

The base compensation range for this role is: zł162,000.00-zł216,750.00

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 contributions, mental health resources, remote work allowance, and flexible work arrangements.

Learning, Growth & Recognition: Access professional development funding, training platforms, employee referral bonuses, opportunities to contribute to impactful projects at Biogen, and social activities.