Manager, Regulatory Affairs - EMEA - Remote

About the role

Worldwide Clinical Trials is a global CRO seeking a senior regulatory affairs professional to lead submissions and ethics committee interactions across EMEA, Asia‑Pacific and Latin America. The role is fully remote and combines strategic regulatory guidance with business development support.

Key responsibilities

• Review study budgets, negotiate contracts and contribute regulatory sections to proposals and feasibility reports.
• Coordinate and manage regulatory and ethics committee submissions, maintaining approvals across multiple regions.
• Provide expert regulatory advice, communicate submission status to sponsors, project managers and medical affairs teams.
• Prepare technical documentation such as IMPDs and IBs, ensuring compliance with ICH GCP and country‑specific requirements.
• Mentor and, when required, line‑manage junior regulatory staff.

Required profile

• Minimum 5‑7 years of senior‑level regulatory or clinical start‑up experience in the pharmaceutical/CRO industry.
• Proven leadership, organizational and planning skills with the ability to handle multiple tasks in a fast‑paced environment.
• Excellent written and verbal communication, capable of presenting information clearly.
• Strong relationship‑building competency, comfortable supporting business development in face‑to‑face meetings.
• Proficiency in cross‑cultural communication and fluency in spoken and written English.