Global Regulatory Submissions Lead, Study Start-up

Medpace; Greater London; In loco; GBP 65.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

PTO and retirement benefits

WFH flexibility after training

Company-sponsored social events

Descrizione del lavoro

Medpace in London is seeking a Regulatory Submissions (Study Start-up) Manager to lead global start-up activities within our Clinical Operations team. The role focuses on coordinating regulatory submissions and ensuring timely approval across regions, while partnering with project teams.

The successful candidate will bring extensive clinical research experience, strong regulatory knowledge for Europe, and proven leadership to drive study start-up deliverables and audits.

Competenze

• Extensive clinical research experience, preferably with CRO involvement.
• Knowledge of Regulatory Submissions within Europe and global submission processes.
• Strong communication and stakeholder management skills.
• Proven leadership in study-start-up and strategic planning.

Mansioni

• Efficiently manage and oversee all global study start-up submissions.
• Perform quality checks on submission documents and essential regulatory materials.
• Prepare and approve informed consent forms and regulatory documents.
• Review regulations to develop proactive solutions for start-up challenges; ensure compliance.
• Present at bid defenses, capabilities meetings, and audits.

Conoscenze

Clinical research experience

Regulatory submissions knowledge

Project management

Communication skills

Formazione

Bachelor's degree in life sciences

Descrizione del lavoro

Medpace in London is seeking a Regulatory Submissions (Study Start-up) Manager to lead global start-up activities within our Clinical Operations team. The role focuses on coordinating regulatory submissions and ensuring timely approval across regions, while partnering with project teams.

The successful candidate will bring extensive clinical research experience, strong regulatory knowledge for Europe, and proven leadership to drive study start-up deliverables and audits.