EU CTR Submissions Lead — CTA Contract (On-site)

SRG; Maidenhead; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

SRG in Maidenhead seeks an experienced Regulatory CTA specialist to manage a portfolio of CTAs, prepare and maintain submission documentation, and guide cross-functional teams through EU CTR processes.

You will advise on submission strategy, monitor milestones, support inspection readiness, and ensure timely compliance with internal and regulatory requirements in a fast-paced, globally collaborating environment.

Qualifications

• At least 5-6 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
• Experience working across cultures in a complex matrix environment.
• Proactive communication and ability to work independently.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new initial CTAs and all maintenance activities.
• Provide advice on submission strategy and country requirements, and support regulatory submission processing of amendments.
• Act as SME on EU CTR submissions and lead CTR transition strategies with stakeholders.
• Lead CTA-specific scientific advice procedures and guide study teams on decision points for submissions.
• Review documents related to clinical trial submissions and ensure adherence to approved processes and timelines.
• Monitor milestones and communicate issues/changes to stakeholders and management.

Skills

Regulatory submissions

CTA experience

Cross-cultural collaboration

Tools

MS Word

MS Excel

PowerPoint

Adobe Acrobat

Global databases

Job description

SRG in Maidenhead seeks an experienced Regulatory CTA specialist to manage a portfolio of CTAs, prepare and maintain submission documentation, and guide cross-functional teams through EU CTR processes.

You will advise on submission strategy, monitor milestones, support inspection readiness, and ensure timely compliance with internal and regulatory requirements in a fast-paced, globally collaborating environment.