Global Regulatory Associate – Clinical Trials

SRG; Maidenhead; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

SRG seeks a Regulatory Associate to provide global regulatory expertise for Clinical Trials. You will be the primary interface between global functions and affiliates to deliver regulatory strategies, operations and outcomes with a focus on CTAs and EU CTR submissions.

You will collaborate across cultures in a matrix environment, manage timelines, and support inspection readiness while ensuring compliant processes and effective communication in English.

Qualifications

• Bachelor’s degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
• Advanced degree in life sciences is preferred.

Responsibilities

• Manage a portfolio of CTAs including preparation and distribution of documentation for new initial CTAs and maintenance activities (amendments, end of trial notifications).
• Provide advice on submission strategy and country requirements; support regulatory submission preparation and amendments.
• Serve as SME on EU CTR submissions, guiding cross-functional teams and training on CTR processes.
• Lead CTA-specific scientific advice procedures and advise study teams on options and timelines.
• Review documents related to clinical trial submissions managed by others (IB, Protocols) and ensure CTR processes meet timelines.
• Monitor milestones and communicate issues to stakeholders and management.
• Support inspection readiness activities as applicable.
• Maintain regulatory intelligence and inform stakeholders of regulatory updates.
• Populate databases and trackers and provide operational support for regulatory systems.
• Provide technical support for document preparation (Excel, PowerPoint).
• Undertake training to ensure compliance with processes and support CTS team activities.

Skills

Regulatory knowledge

Project management

Cross-cultural collaboration

English fluency

Stakeholder management

Education

Bachelor’s degree in life sciences

Advanced life sciences degree preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat

Global databases

Job description

SRG seeks a Regulatory Associate to provide global regulatory expertise for Clinical Trials. You will be the primary interface between global functions and affiliates to deliver regulatory strategies, operations and outcomes with a focus on CTAs and EU CTR submissions.

You will collaborate across cultures in a matrix environment, manage timelines, and support inspection readiness while ensuring compliant processes and effective communication in English.