EU CTR Submission Lead

Biogen, Inc.; Indiana (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Biogen, Inc. is looking for an EU CTR Submission Lead to oversee the regulatory submissions for clinical trials under the EU Clinical Trial Regulation. The role involves strategic planning, cross-functional coordination, and ensuring compliance with all submissions.

Ideal candidates will hold a Bachelor’s or Master’s in Life Sciences, possess over 5 years of experience with EU CTR submissions, and have excellent communication and problem-solving skills. This position offers the opportunity for hybrid work.

Qualifications

• 5+ years’ experience with EU CTR submissions and advanced CTIS expertise.
• Proven ability to lead complex submission programs.
• Strong understanding of EU CTR timelines and dossier content.

Responsibilities

• Lead planning and execution of regulatory submissions.
• Serve as SME for EU CTR and CTIS processes.
• Ensure submissions adhere to EU CTR 536/2014, ICH-GCP.

Skills

EU CTR submissions expertise

CTIS knowledge

Strong communication skills

Problem-solving skills

Education

Bachelor’s or Master’s in Life Sciences or related field

Job description

## EU CTR Submission LeadApplyremote type: Hybridlocations: Baar, Switzerlandtime type: Full timeposted on: Posted Todayjob requisition id: REQ23501Position Summary: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 Responsibilities1. 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 communicationJob Level: Management