EU CTR Submission Group Lead job opportunity at Biogen Inc..

Home Jobs In Switzerland Tag: Job EU CTR Submission Group Lead position at Biogen Inc.


DateMore Than 30 Days Ago bot
Biogen Inc. EU CTR Submission Group Lead
Experience: 5-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeGeneral
loacation Baar, Switzerland, Switzerland
loacation Baar, Switzerl..........Switzerland

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   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 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.

Other Ai Matches

Clinical Trial Application Lead, Biogen West Coast Hub Applicants are expected to have a solid experience in handling Biogen West Coast Hub related tasks
Principal Clinical RBQM Programmer Applicants are expected to have a solid experience in handling Job related tasks
Head of Immunology Communications Applicants are expected to have a solid experience in handling Job related tasks
Sr Medical Manager, Lupus - US Medical Affairs Applicants are expected to have a solid experience in handling Lupus - US Medical Affairs related tasks
Senior Analyst, Payroll (12 months limited fixed term contract) Applicants are expected to have a solid experience in handling Payroll (12 months limited fixed term contract) related tasks
Co-op, Quality Control Microbiology Applicants are expected to have a solid experience in handling Quality Control Microbiology related tasks
remote-jobserver Remote
Clinical Trial Management PV Lead Applicants are expected to have a solid experience in handling Job related tasks
Associate Director, Field Commercial training Partner - Biogen Intercontinental Region Applicants are expected to have a solid experience in handling Field Commercial training Partner - Biogen Intercontinental Region related tasks
Sr Manager, Rare Disease Customer Engagement Excellence (f/m/d) Applicants are expected to have a solid experience in handling Rare Disease Customer Engagement Excellence (f/m/d) related tasks
Senior Category Manager, Direct Materials Applicants are expected to have a solid experience in handling Direct Materials related tasks
Neuropsychiatry Access Navigator – Central Applicants are expected to have a solid experience in handling Job related tasks
Intern, Quality Control Microbiology Applicants are expected to have a solid experience in handling Quality Control Microbiology related tasks
Senior Product Marketing Manager - Rare Disease Applicants are expected to have a solid experience in handling Job related tasks
Alternance - Assistant(e) Chef de Produit Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Immunology Thought Leader Liaison SLE Rheumatology Applicants are expected to have a solid experience in handling Job related tasks
Senior Report Developer Applicants are expected to have a solid experience in handling Job related tasks
Global Commercialization Director, MVI Applicants are expected to have a solid experience in handling MVI related tasks
Neurology Key Account Manager Applicants are expected to have a solid experience in handling Job related tasks
Director, CMC Asset Lead Applicants are expected to have a solid experience in handling CMC Asset Lead related tasks
Development Asset Lead (R&D) Applicants are expected to have a solid experience in handling Job related tasks
International Commercial Lead SMA Applicants are expected to have a solid experience in handling Job related tasks
Value & Access Manager Applicants are expected to have a solid experience in handling Job related tasks
Sr Manufacturing Specialist I, MTO Applicants are expected to have a solid experience in handling MTO related tasks