Regulatory & Start-Up Specialist

This is an exciting contract opportunity for an experienced Regulatory & Start-Up Specialist to support site activation activities at a country level. Working on behalf of a leading international organisation driving innovation in clinical trials, this role plays a key part in ensuring studies start on time and in full compliance with regulatory expectations. It's a chance to contribute to projects that are ultimately improving patient outcomes, while collaborating with talented professionals across clinical operations, project management, and regulatory functions.

Your role as Regulatory & Start-Up Specialist

• Serve as the primary point of contact for assigned studies, liaising with investigative sites, project teams and site activation managers to drive progress.

• Coordinate the preparation, collection, and review of site regulatory documents, ensuring they meet local and international requirements.

• Maintain essential study documentation and tracking systems with accurate, up-to-date project information.

• Monitor start-up milestones, proactively identifying any delays and implementing contingency measures where needed.

• Provide expert input on local regulatory timelines and processes to support robust project planning.

• Oversee quality control checks on site documentation and maintain clear communication on status with internal stakeholders.

Experience and qualifications for the Regulatory & Start-Up Specialist role

• Bachelor's degree in life sciences or related field, or equivalent combination of education and experience.

• At least 3 years' clinical research experience, with a strong background in site activation or regulatory submissions.

• Solid understanding of GCP/ICH guidelines and applicable local regulatory requirements.

• Proven ability to manage multiple projects simultaneously and prioritise effectively under deadlines.

• Strong communication, negotiation, and interpersonal skills to build trusted relationships with internal teams and site staff.

• Comfortable working independently and providing insights on local regulatory processes to global teams.

For immediate consideration, or to explore other contract opportunities within clinical research, please apply today or get in touch directly.