EU CTR Submission Specialist

Responsibilities

• 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.
• 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.
• 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.
• 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
• About Global Business Services (GBS)
• #LI-Hybrid
• Job Level: Professional
• Additional Information
• The base compensation range for this role is: zł162,000.00-zł216,750.00

Benefits

Additional Information

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.

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