Global Regulatory Submissions Lead

Premier Research; United States; On-site; 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 drive regulatory strategy and submissions across regions. You will partner with sponsors and project teams to ensure timely, compliant CTAs, documents, and approvals, in both biotech and medtech contexts.

You will lead start-up activities, manage regulatory risks, and mentor junior staff, while aligning with budgets and timelines in a fast-paced global environment.

Qualifications

• University degree in life sciences or related field.
• 8–10 years in regulatory submissions with at least 6 years in lead roles.
• Experience managing submissions for complex, multi-region trials.
• Hands-on CTIS system experience.
• Strong knowledge of ICH/GCP, FDA/EU regulations, ISO14155.
• Ability to interpret directives and guide teams to compliance.
• Ability to meet budgets and timelines.
• Collaborative team player with leadership skills.
• Aptitude to multitask in a fast-paced environment.
• Excellent organization and time management.

Responsibilities

• Lead regulatory strategy, submissions, and approvals across regions.
• Coordinate CTAs, ethics approvals, and regulatory packages.
• Ensure document readiness and regulatory compliance.
• Oversee start-up activities and country/site activation.
• Manage budgets and risk for regulatory and start-up work.
• Coach and mentor junior staff and support business development.

Skills

Regulatory leadership

Regulatory submissions

Project management

Cross-border trials

Education

University degree in life sciences

Pharmacy/Medicine degree

Tools

CTIS system

Job description

Premier Research is seeking a Senior Regulatory Submissions Lead to drive regulatory strategy and submissions across regions. You will partner with sponsors and project teams to ensure timely, compliant CTAs, documents, and approvals, in both biotech and medtech contexts.

You will lead start-up activities, manage regulatory risks, and mentor junior staff, while aligning with budgets and timelines in a fast-paced global environment.