Position 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 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
Job Level: Professional
Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
