Global Regulatory Submissions Lead

Medpace; Stirling; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Office-based culture with occasional W

Health, retirement, PTO benefits

Company-sponsored social events

On-site mentors

Job summary

Medpace is seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. The role focuses on managing global start-up, ensuring high-quality submission documents, and presenting at audits and defenses.

The position requires extensive clinical research experience, regulatory knowledge in Europe, and strong communication and leadership abilities. An office-based, collaborative environment with ongoing growth opportunities is offered.

Qualifications

• Extensive experience in clinical research, preferably with a CRO.
• Knowledge of Clinical Trial Applications within Europe.
• Strong oral and written communication skills.
• Team oriented with leadership abilities.

Responsibilities

• Efficiently manage and execute all aspects of global start-up.
• Quality checks on submission documents and site essential documents.
• Prepare and approve informed consent forms.
• Review regulations to address start-up issues and challenges.
• Present during bid defenses, capabilities meetings, and audits.

Skills

Clinical research

Regulatory knowledge

Leadership

Communication

Teamwork

Job description

Medpace is seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team. The role focuses on managing global start-up, ensuring high-quality submission documents, and presenting at audits and defenses.

The position requires extensive clinical research experience, regulatory knowledge in Europe, and strong communication and leadership abilities. An office-based, collaborative environment with ongoing growth opportunities is offered.