Clinical Submissions Specialist (Regulatory & Start-Up)

Medpace; Stirling; On-site; GBP 32,000 - 52,000; Full time

Job summary

Medpace is seeking a Regulatory Submissions Coordinator to support our Regulatory Submissions team in a full-time, on-site role in the UK. The position requires coordinating start-up submissions, reviewing regulatory documents, and ensuring compliance with guidelines to accelerate clinical trial timelines.

The ideal candidate has a Life Sciences degree with at least 2 years of Regulatory Submissions experience and strong organizational and communication skills to manage timelines and collaborate

Qualifications

• Bachelor's degree in Life Sciences.
• At least 2 years of work experience as Regulatory Submissions Coordinator.
• Hands-on experience preparing, reviewing, and submitting regulatory documentation.
• Knowledge of Microsoft Office.
• Excellent organization and communication skills.
• Great attention to detail.

Responsibilities

• Provide day-to-day departmental support activities to Regulatory Submissions Coordinators.
• Maintain database and spreadsheets to facilitate tracking and documentation of departmental activities.
• Collect, review, organize, and assemble regulatory start-up submissions.
• Perform other tasks as needed.
• Prepare, review, and file clinical trial applications.
• Communicate with research sites to collect all essential documents before site starts to enrol patients.
• Provide input on regulatory submissions documents and timelines; ensure timely study start-up.
• Ensure submissions comply with applicable regulations and guidance documents.

Skills

Excellent organization

Excellent communication

Attention to detail

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Job description

Medpace is seeking a Regulatory Submissions Coordinator to support our Regulatory Submissions team in a full-time, on-site role in the UK. The position requires coordinating start-up submissions, reviewing regulatory documents, and ensuring compliance with guidelines to accelerate clinical trial timelines.

The ideal candidate has a Life Sciences degree with at least 2 years of Regulatory Submissions experience and strong organizational and communication skills to manage timelines and collaborate