Regulatory Associate – CTA

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

• Office- Maidenhead (hybrid) – 3 days on site

SRG are partnered with a global biopharmaceutical company with focus and capabilities to address some of the world’s greatest health challenges. Our client combines advanced science, expertise and passion to solve serious health issues and have a remarkable impact on people’s lives.

JOB SUMMARY

The Regulatory Associate is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes.

KEY DUTIES AND RESPONSIBILITIES

• Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc.
• Provide advice on submission strategy, country requirements, etc. as well as operational support for Regulatory submission preparation and processing of amendments.
• SME on all aspects of EU CTR submissions including platform and complex trials, guiding cross functional teams through the process and providing training and education on the processes. Define strategy for CTR transitions and initial submission alongside other key stakeholders. Modify processes and strategy based on lessons learned.
• Lead CTA specific scientific advice procedures, including advising study teams and management of the different options and leading strategies on when to utilize
• Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols.
• Ensure approved company CTA processes are followed within agreed timelines.
• Good understanding of CTR process and requirements.
• Monitor key project milestones (actual vs. planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures.
• Support inspection readiness activities when applicable
• Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly.
• Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
• Provide technical support on document preparation e.g. Excel spreadsheets, Power Point presentations.
• Undertake all necessary training in order to achieve compliance with internal/external processes
• Provide operational support for the CTS Team as required.
• Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company
• This position reports to the Associate Director, CTS

Education

• Required: Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
• Preferred: Relevant advanced degree in life sciences is preferred

Experience

• At least 5-6 years CTA experience, preferably in global clinical trial submissions to regulatory agencies.
• Experience working effectively across cultures and in a complex matrix environment
• Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
• Proactive verbal and written communication style at all levels.
• Shows high level of initiative and ability to work independently
• Has excellent communication/presentation skills, written and verbal; fluency in English.
• Strong proven personal development and motivational skills.
• Strong interpersonal, organisational and team working skills.
• Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites
• Has critical reasoning skills including the identification and resolution of complex problems and/or elevation of issues to relevant line functions and management.
• Strong Project Management skills, able to manage multiple activities in line with
• business priorities and study time goals
• Understands business needs and impact of regulatory issues on these.