Remote Regulatory Affairs Manager: EU CTR Strategy Lead

Freyr Solutions; Remote; GBP 125,000 - 150,000; Full time

Job summary

A leading global regulatory organization is seeking a Regulatory Affairs Manager to support the development and execution of global regulatory strategies for investigational submissions, particularly for EU and UK regulations. This remote role requires expertise in regulatory compliance, active collaboration with multidisciplinary teams, and the ability to manage complex regulatory deliverables. Ideal candidates will have strong attention to detail, knowledge of clinical trial regulations, and experience with Health Authority Portals, contributing to projects that ensure patient safety and transparency across global markets.

Benefits

Collaborative global regulatory team

Opportunity to shape regulatory strategies

Exposure to complex submissions

Qualifications

• Knowledge supporting EU Clinical Trial Regulation and UK regulations.
• Demonstrated performance in managing time-intensive deliverables.
• Strong attention to detail in data entry accuracy.

Responsibilities

• Develop global regulatory strategy and manage investigational submissions.
• Collaborate with global regulatory team on regulatory plans.
• Research regulatory intelligence for innovative solutions.

Skills

Overall knowledge of EU Clinical Trial Regulation

Attention to detail

Knowledge of Document Management Systems

Strong computer skills in Microsoft Office

Experience in Health Authority Portals

Recent CTA Regulatory application experience

Job description

A leading global regulatory organization is seeking a Regulatory Affairs Manager to support the development and execution of global regulatory strategies for investigational submissions, particularly for EU and UK regulations. This remote role requires expertise in regulatory compliance, active collaboration with multidisciplinary teams, and the ability to manage complex regulatory deliverables. Ideal candidates will have strong attention to detail, knowledge of clinical trial regulations, and experience with Health Authority Portals, contributing to projects that ensure patient safety and transparency across global markets.