Regulatory Start‑Up Lead (EMEA)

About the role

The Regulatory Start‑Up Lead (RSL) is responsible for planning, preparing, and reviewing ethics and regulatory authority submissions for clinical trials across the EMEA region. The role ensures compliance with ICH‑GCP guidelines and local regulations to achieve timely trial approvals.

Key responsibilities

• Act as the primary contact for the Regulatory Start‑Up Manager, Project Manager and sites on country‑ and site‑level start‑up activities.
• Provide expert guidance on local regulations, keeping up‑to‑date with changes that affect trial approvals.
• Deliver submission timelines and deadline metrics for regulatory authorities, ethics committees, and review boards.
• Coordinate multi‑country regulatory teams and align strategic priorities with project managers.
• Ensure start‑up activities meet agreed timelines, budgets, quality standards and company policies.
• Participate in bid defence meetings, proposal support, and vendor audits as a subject‑matter expert.
• Mentor junior team members and act as a backup line manager.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences or related field.
• 5+ years of experience in clinical research, regulatory affairs or trial start‑up within a CRO, pharmaceutical or biotechnology environment.
• Strong knowledge of ICH‑GCP and regional regulatory processes.
• Proven ability to balance stakeholder needs and drive proactive solutions.

Required skills

What we offer

• Opportunity to lead regulatory start‑up activities across multiple EMEA countries.
• Collaborative, cross‑functional environment with exposure to global clinical programs.
• Professional development and mentorship responsibilities.