Clinical Trial Regulatory Affairs Expert

About the role

Roche is seeking a Clinical Trial Regulatory Affairs Expert to lead strategic oversight of clinical trial regulatory activities across the EEA and ROW after a 4–6 month mentorship period. The role involves coordinating core CTA documents, supporting international trials, and advising program managers on regulatory requirements.

Key responsibilities

• Manage core CTAs and common documents for EEA and ROW, including planning, compilation, dispatch, and tracking of submissions and approvals.
• Attend key SMT/RAFT meetings and interact with stakeholders for CTA‑related activities.
• Support international clinical trials in collaboration with Program Managers.
• Work with senior experts on knowledge sharing and information maintenance.
• Advise on external and internal CTA requirements and country‑specific changes.

Required profile

• At least 1 year of experience in clinical trial activities.
• BS/BA degree or minimum 3 years relevant pharmaceutical industry experience.
• Excellent planning, organizational, and communication skills.
• Fluent in written and spoken English.

Required skills

• Experience with Veeva RIM.
• Experience with CTIS.

What we offer

• Development opportunities, language courses, training, and international assignments.
• Hybrid work model (2 days/week office).
• Annual bonus, transportation allowance, home‑office equipment, health and life insurance, full salary during first 9 sick days, eyeglasses settlement, one‑time payments for life events.
• Additional holidays and bonus payments for loyalty.