Global Regulatory Affairs Manager: EU/UK CTA Strategy

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

Job summary

A global Regulatory Solutions organization is seeking a Regulatory Affairs Manager to support the development and execution of global regulatory strategies for investigational submissions, focusing on EU and UK Clinical Trial Regulations (CTR). The role involves managing lifecycle activities, ensuring compliance with regulatory requirements, and collaborating with a global team. Ideal candidates will have substantial experience in regulatory submissions and a strong attention to detail. Join the team to work on impactful initiatives supporting patient safety globally.

Benefits

Collaborative work environment

Opportunity for professional growth

Qualifications

• Overall knowledge of EU Clinical Trial Regulation (CTR) and UK regulations related to clinical trials.
• Demonstrated performance in managing and producing time-intensive deliverables.
• Strong attention to detail in data entry accuracy and procedural compliance.
• Knowledge of Document Management Systems, preferably Documentum.
• Experience submitting regulatory submissions using Health Authority Portals.
• Strong computer skills in Microsoft Office and SharePoint.
• Recent CTA Regulatory application experience is essential.

Responsibilities

• Develop global regulatory strategy and manage lifecycle regulatory activities.
• Collaborate with global regulatory team members on regulatory plans.
• Research regulatory intelligence and innovative pathways for submissions.
• Perform quality control on prepared CTA submissions.
• Coordinate CTA activities with multidisciplinary teams.
• Support preparation and submission of CTA submissions.

Job description

A global Regulatory Solutions organization is seeking a Regulatory Affairs Manager to support the development and execution of global regulatory strategies for investigational submissions, focusing on EU and UK Clinical Trial Regulations (CTR). The role involves managing lifecycle activities, ensuring compliance with regulatory requirements, and collaborating with a global team. Ideal candidates will have substantial experience in regulatory submissions and a strong attention to detail. Join the team to work on impactful initiatives supporting patient safety globally.