EU CTR Submission Group Lead

Baar - Switzerland

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Position Summary

TheEU-CTREU-CTRSubmissions GroupLead isa critical leadership role overseeing operational activities related toend-to-endtrialsubmissions and lifecycle management under the EU Clinical Trials Regulation (EU CTR 536/2014). This role ensures the efficienttimely and compliant execution of submissions via the Clinical Trials Information System (CTIS).

Responsible for managing a team of submission specialists andsubmission leads the position providesleadership compliance oversight and operational excellence for EU clinical trials. The roleis alsothe primary escalation and decision-making point for EU-CTR operational challenges ensuring alignment with organizationalobjectives 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

Bachelors or Masters 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

Job Level: Management

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 onto 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.

Position SummaryTheEU-CTREU-CTRSubmissions GroupLead isa critical leadership role overseeing operational activities related toend-to-endtrialsubmissions and lifecycle management under the EU Clinical Trials Regulation (EU CTR 536/2014). This role ensures the efficienttimely and compliant execution o...