Associate Start Up – Regulatory Manager

Role Overview

• Support the execution of site activation and maintenance activities, including pre‑award and bid defence activities
• Assist in developing and maintaining Regulatory & Start‑Up Management Plans aligned to project scope and timelines
• Contribute to defining regulatory strategy, submission pathways, and authorisation requirements
• Prepare, review, and track regulatory and contractual documentation, ensuring timely execution
• Identify regulatory challenges and support the development of practical solutions
• Monitor site performance metrics and support compliance with SOPs, GCP, ICH, and applicable regulations
• Collaborate with regional, country, and global teams to deliver study milestones
• Maintain accurate records within CTMS, databases, timelines, and tracking tools
• Support Quality Management activities to ensure appropriate standards are maintained
• Provide input into client communications, presentations, or training where required
• Support budget planning and study tracking activities as needed
• Actively develop leadership skills, including mentoring or supporting junior colleagues

Requirements

• A Bachelor’s degree in a related scientific or clinical field
• Typically 2–3 years’ relevant experience in clinical research
• Around 3 years’ clinical research experience, including exposure to leadership or coordination responsibilities
• Good knowledge of clinical research processes, medical terminology, and regulations
• Experience working with clinical systems and strong Microsoft Office skills
• Strong communication, organisational, and interpersonal skills
• The ability to manage multiple tasks and priorities with attention to detail
• Confidence working both independently and collaboratively
• A proactive, solution‑focused mindset with the ability to build strong working relationships

Tech Stack

• Google Cloud Platform

Benefits

• Excellent opportunity for someone looking to step into greater responsibility within Regulatory & Start‑Up
• Gain exposure to global studies
• Develop leadership capability within a supportive and collaborative clinical research environment