EU CTR Submission Lead

Biogen (Switzerland) seeks a Senior EU CTR Submission Lead in Baar to manage the full lifecycle of clinical trial submissions via CTIS, ensuring regulatory compliance and strategic coordination across the EU/EEA.

The company is looking for a senior technical leader to oversee the complete regulatory submission process for clinical trials under the EU Clinical Trial Regulation (EU CTR 536/2014) through the Clinical Trials Information System (CTIS). This position requires providing strategic planning, cross-functional coordination, and subject matter expertise to ensure timely, high-quality, and compliant submissions across the European Union and European Economic Area. While the role involves mentoring junior team members, it does not include direct line management responsibilities.

Responsibilities

• Direct the planning and execution of Initial Clinical Trial Applications, Part I and Part II submissions, Substantial Modifications, and all activities within the CTIS lifecycle.
• Manage the preparation and submission of Requests for Information, ensuring responses are delivered on time and meet quality standards.
• Provide expert guidance on end-of-study activities, including End-of-Trial notifications, Summary of Results, Lay Summaries, Clinical Study Reports, and their revisions.
• Perform quality oversight to guarantee alignment with EU CTR regulations, EMA guidance, and internal standard operating procedures.
• Act as the primary subject matter expert for EU CTR and CTIS processes, interpreting regulatory expectations for the team.
• Coordinate submission readiness with internal stakeholders, including Regulatory Affairs, Clinical Trial Delivery, Clinical Trial Acceleration Units, Country and Site Operations, and Safety teams.
• Lead meetings for the EU CTR Study Submission Team to align on submission strategies and timelines.
• Ensure all submissions comply with EU CTR 536/2014, ICH-GCP, EMA guidance, and national requirements.
• Support internal and external audits and inspections related to submission activities.
• Contribute to the development and maintenance of standard operating procedures, work instructions, and templates.
• Manage complex CTIS activities, including dossier creation, document uploads, metadata accuracy, lifecycle management, and public disclosure settings.
• Troubleshoot system issues and liaise with the EMA as needed.

Requirements

• Bachelor’s or Master’s degree in Life Sciences or a related field.
• At least five years of experience with EU CTR submissions and advanced expertise in CTIS.
• 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.

What the company offers

• Stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
• Unparalleled opportunities for learning, growth, and expanding their skills.
• Culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

About the company

Biogen (Switzerland) is a mid-sized biotechnology company with a global team committed to excellence and a pioneering spirit. The organization values diverse backgrounds, cultures, and perspectives, believing they make the company stronger and more innovative. The mission is to care deeply, achieve excellence, and change lives, focusing on building teams where every employee feels empowered and inspired.

• Global team with a commitment to excellence, and a pioneering spirit.
• Mid-sized biotechnology company.
• Team encompasses some of the most talented and passionate achievers.
• Mission: Caring Deeply. Achieving Excellence. Changing Lives.
• Diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company.
• Focused on building teams where every employee feels empowered and inspired.