EU CTR Submission Group Lead

Position Summary

The EU-CTR EU-CTR Submissions Group Lead is a critical leadership role overseeing operational activities related to end-to-end trial submissions and lifecycle management under the EU Clinical Trials Regulation (EU CTR 536/2014). This role ensures the efficient, timely, and compliant execution of submissions via the Clinical Trials Information System (CTIS). 

Responsible for managing a team of submission specialists and submission leads, the position provides leadership, compliance oversight, and operational excellence for EU clinical trials. The role is also the primary escalation and decision-making point for EU-CTR operational challenges, ensuring alignment with organizational objectives regulatory requirements, and clinical trial timelines. 

Key Responsibilities

1. Regulatory Submission Leadership

• Oversee planning and execution of Initial CTAs, Part I & II submissions, Substantial Modifications (SMs), and lifecycle management in CTIS.

• Ensure timely, high-quality RFI responses.

• Lead end-of-study submissions: EoT notifications, Summary of Results, Lay Summary, CSR/CSRr packages.

• Ensure overall compliance with EU CTR, EMA guidance, and internal SOPs.

2. Strategic & Operational Oversight

• Define submission strategies and oversee implementation across assigned programs.

• Collaborate with internal stakeholders (Regulatory Affairs, Clinical Trial Delivery and Clinical Trial Acceleration Units, Country & site Operations and Safety).

• Identify process gaps and implement operational improvements.

• Represent the submission Study Management Team meetings and leadership discussions.

3. Compliance & Quality Governance

• Ensure adherence to EU CTR 536/2014, ICH-GCP, and evolving EMA guidance.

• Lead inspection and audit readiness for CTIS processes.

• Maintain SOPs and ensure documentation accuracy and consistency.

4. CTIS Expertise & System Ownership

• Act as senior SME for CTIS operations, troubleshooting, training, and system governance.

• Oversee metadata accuracy, dossier alignment, public disclosure settings, and lifecycle completeness.

• Liaise with EMA for complex system issues.

5. People Leadership & Team Management

• Manage a team of EU CTR Submission Specialists and leads, including hiring, performance reviews, development planning, and coaching.

• Distribute workload effectively and ensure adequate resource allocation.

• Lead training, capability building, and continuous improvement initiatives.

• Foster a culture of quality, collaboration, and accountability.

Qualifications & Experience

• Bachelor's or Master's in Life Sciences or related field.

• 5+ years experience with EU clinical trial submissions and CTIS.

• Demonstrated people management experience.

• Strong knowledge of EU CTR results reporting and transparency requirements.

• Excellent leadership, communication, and decision-making skills.

• Experience in pharma, biotech, or CRO.

• Experience leading submission teams globally or regionally.

• Expertise in public disclosure and anonymization

Core Competencies & Skills

• Leadership and team development

• Strategic thinking

• Advanced regulatory expertise

• Operational excellence

• Strong communication skills

• Quality mindset and attention to detail

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 our DE&I efforts.

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.