Regulatory Submissions Specialist - Flexible & Growth-Oriented

Medpace; Stirling; On-site; GBP 30,000 - 42,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits

Structured career paths

Job summary

Medpace is seeking a Regulatory Submissions Coordinator to support day-to-day regulatory activities and ensure timely start-up submissions. You will maintain databases and collaborate with research sites to collect essential documents, supporting timelines from start-up through to study enrollment.

The role requires a Life Sciences degree, 2+ years of experience in regulatory submissions, and strong organization and communication skills.

Qualifications

• Bachelor's degree in Life Sciences is required.
• At least 2 years of experience as Regulatory Submissions Coordinator.
• Hands-on experience preparing, reviewing, and submitting regulatory documents.
• Proficiency in Microsoft Office and strong organizational skills.

Responsibilities

• Provide day-to-day departmental support to Regulatory Submissions Coordinators.
• Maintain database and spreadsheets to track departmental activities.
• Collect, review, organize, and assemble regulatory start-up submissions.
• Prepare, review, and file clinical trial applications.
• Communicate with research sites to collect essential documents before site starts to enroll patients.
• Provide input on regulatory submission documents and maintain study timelines.
• Ensure submissions comply with applicable regulations and guidance documents.

Skills

Organizational skills

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 day-to-day regulatory activities and ensure timely start-up submissions. You will maintain databases and collaborate with research sites to collect essential documents, supporting timelines from start-up through to study enrollment.

The role requires a Life Sciences degree, 2+ years of experience in regulatory submissions, and strong organization and communication skills.