EU CTR Regulatory Lead — Clinical Trial Submissions

SRG; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

SRG is seeking an experienced Regulatory Consultant to join our Clinical Trial Strategy & Submissions team in Maidenhead. Responsibilities include managing CTAs, amendments and end-of-trial notifications to support global clinical development.

On-site 3 days a week (Tue–Thu). The role requires 5–6+ years CTA experience, strong EU CTR knowledge, cross-functional collaboration, and excellent written and verbal English.

Qualifications

• 5–6+ years CTA experience, preferably global submissions.
• Strong understanding of EU CTR processes and requirements.
• Experience working across cultures within a complex matrix organisation.
• Excellent written and verbal communication; fluent in English.

Responsibilities

• Manage CTAs, amendments and end-of-trial notifications for regulatory submissions.
• Provide regulatory advice on submission strategies and country-specific requirements.
• Act as SME on EU CTR submissions, including complex and platform trials.
• Guide cross-functional teams through EU CTR processes and training.
• Develop strategies for CTR transitions and initial submissions with stakeholders.
• Lead CTA-specific scientific advice and options for study teams.
• Review and provide input into clinical trial submission documents.
• Ensure regulatory processes and timelines are followed.
• Monitor milestones and communicate risks and changes to stakeholders.
• Support inspection readiness activities as required.
• Maintain regulatory databases and trackers within required timelines.
• Provide technical support with regulatory documentation (Excel, PowerPoint).
• Complete training to ensure compliance with processes.
• Provide broader operational support to the team.

Skills

CTA experience

EU CTR knowledge

Stakeholder management

MS Word

Excel

PowerPoint

Adobe Acrobat

Regulatory databases

English fluency

Project management

Cross-functional teamwork

Independent working

Education

Bachelor's degree in Life Sciences

Advanced degree (life sciences)

Tools

Regulatory databases

Job description

SRG is seeking an experienced Regulatory Consultant to join our Clinical Trial Strategy & Submissions team in Maidenhead. Responsibilities include managing CTAs, amendments and end-of-trial notifications to support global clinical development.

On-site 3 days a week (Tue–Thu). The role requires 5–6+ years CTA experience, strong EU CTR knowledge, cross-functional collaboration, and excellent written and verbal English.