Senior Regulatory Affairs Specialist - EU - Remote

Overview

The Senior Regulatory Affairs Specialist will be a subject matter expert supporting regulatory submissions and site activation for clinical trials across the EU.

In Short

• Work with a global team to navigate complex regulatory landscapes.
• Lead submissions to regulatory authorities and coordinate with ethics committees.
• Ensure compliance with evolving regulations for clinical trials.
• Mentor junior staff and review documentation for global standards.
• Manage documents required for regulatory submissions and site activation.
• Proactively identify potential issues and propose solutions.
• Build relationships with local investigators and site personnel.
• Adapt to changing environments and prioritize tasks effectively.
• Contribute to a diverse and inclusive workplace culture.
• Help improve lives through innovative medical product approvals.

Requirements

• Degree in medical, biological, physical, health, pharmacy or related science.
• Minimum three years of experience in clinical research or regulatory functions.
• Experience with regulatory processes in the UK and/or EU-CTR.
• Good knowledge of ICH GCP and relevant clinical research guidance.
• Fluency in local language and working knowledge of English preferred.
• Strong organizational, planning, and management skills.
• Ability to work in a team-oriented environment.
• Self-motivated with a proactive approach to problem-solving.
• Understanding of local healthcare systems and cultural norms.
• Ability to adapt between detailed and strategic activities.

Benefits

• Opportunity to work in a diverse and inclusive environment.
• Access to professional development and mentoring.
• Be part of a mission-driven organization focused on improving lives.
• Collaborative and supportive team culture.
• Flexible work arrangements in a remote setting.