Regulatory Submissions Coordinator (Study Start Up)

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking an experienced Regulatory Submissions Coordinator to join our Clinical Operations team in the UK. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Please note that this is a office-based position in London

Responsibilities

• Prepare, review, and file initial clinical trial applications to regulatory authorities;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise team members on changing regulations and compliance requirements;
• Maintain the Clinical Trial Management System and ensure timely filing of documents;
• Collection of essential documents and preparation essential documents packages for drug release.

Qualifications

• A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
• Experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries;
• Relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
• Knowledge of regulatory guidelines in the UK;
• Excellent organizational and prioritization skills;
• Use to work independently with a proactive approach;
• Knowledge of Microsoft Office;
• Great attention to detail and excellent oral and written communication skills.

Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

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