Global Regulatory Submissions Lead: Strategy & Start-Up

Premier Research Group; Northern (KY); Hybrid; USD 131,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle.

You will coordinate CTIS activities, work with sponsors and project teams, and ensure document readiness and regulatory compliance for complex multi-region studies.

Qualifications

• 8–10 years’ experience in regulatory submissions or related roles.
• Experience leading submissions across multiple regions.
• Experience with CTIS system and regulatory lifecycle.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries.
• Coordinate CTAs, ethics approvals, and regulatory applications for multi-region studies.
• Review regulatory documents to ensure compliance and quality.

Skills

Regulatory strategy

CTIS experience

Regulatory submissions

ICH/GCP knowledge

FDA/EU regulations

Education

University degree in pharmacy/medicine/related sciences

Job description

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle.

You will coordinate CTIS activities, work with sponsors and project teams, and ensure document readiness and regulatory compliance for complex multi-region studies.