Global Regulatory & Site Activation Expert

Worldwide Clinical Trials; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Regulatory Start-Up Specialist to lead end-to-end site activation and regulatory submissions for global projects. You will coordinate country-level activities, customize regulatory documents, and manage timelines while collaborating with RAM and project teams.

The role requires strong organizational skills, regulatory knowledge, and the ability to communicate effectively across a diverse set of sites and stakeholders in a fast-paced CRO environment.

Qualifications

• 2-year college or equivalent with science focus
• Minimum 2 years of experience in clinical research
• Experience in site activation and regulatory function preferred
• Knowledge of ICH GCP and country regulations
• Multilingualism preferred; fluent in local language; working knowledge of English

Responsibilities

• Support end-to-end site start-up from site identification to activation
• Act as country-level regulatory contact for assigned studies
• Customize country-specific patient information sheets and regulatory documents
• Review country timelines for assigned studies
• Communicate status and plans to RAM and project team
• Track regulatory documents by site/country and report to RAM
• Identify risks and mitigation strategies at country/site level
• Provide regulatory strategy input to RAM/project team
• Maintain updates on regulatory requirements and intelligence
• Ensure SOPs and ICH GCP compliance
• Assist with translation reviews of submissions

Skills

Organizational skills

Planning

Communication skills

Multilingualism

Regulatory process awareness

MS Office

Education

2-year college science

Tools

MS Office

Job description

Worldwide Clinical Trials is seeking a Regulatory Start-Up Specialist to lead end-to-end site activation and regulatory submissions for global projects. You will coordinate country-level activities, customize regulatory documents, and manage timelines while collaborating with RAM and project teams.

The role requires strong organizational skills, regulatory knowledge, and the ability to communicate effectively across a diverse set of sites and stakeholders in a fast-paced CRO environment.