Clinical Trial Regulatory Affairs Expert (CTA) – EEA and ROW

About the role

After a 4-6 month mentorship period, the CTA Regulatory Expert acts as the strategic architect for the Common Technical Document (CTA) process across the EEA and ROW, overseeing clinical trial regulatory activities. The role works closely with Regulatory Programme Managers (EU Partner/GRL) to own the regulatory framework and drive its execution toward global milestones. It is a one-year fixed-term position.

Key responsibilities

• Manage core CTAs or common documents and amendments for EEA and ROW countries: planning, compilation, dispatch, coordination with internal departments and affiliates, and tracking of submissions and approvals in the appropriate systems
• Attend key SMT/RAFT meetings during the planning phase of a clinical trial and as appropriate, in agreement with the Programme Managers
• Interact with stakeholders on CTA-related activities and support clinical trials in international countries on an as-needed basis with the Programme Manager
• Work with the senior Clinical Trial Regulatory Affairs Expert or group manager on knowledge sharing and information maintenance
• Advise Programme Managers on external and internal CTA requirements and country-specific changes

Required profile

• At least 1 year of experience on clinical trial-related activities
• BS/BA degree or at least 3 years of relevant experience in the pharmaceutical industry
• Fluent written and spoken English
• Experience with Veeva RIM and CTIS is an advantage

Required skills

• Excellent planning, organizational and communication skills
• Ability to work in a team-based, customer-focused environment and to coordinate multiple activities in parallel
• Attention to detail, commitment to agreed timelines and ability to work under stress

What we offer

• Starting salary of 2,700 EUR gross per month, depending on experience, skills and qualifications
• Annual bonus, monthly transportation allowance, home office equipment, health and life/accident insurance, full salary for the first 9 days of sick leave, eyeglasses settlement and one-time payments for life events
• Additional holidays and bonus for loyalty, international assignments and internal mobility
• Hybrid model (2 days per week in the office)
• Free language courses and training, and development opportunities