Regulatory Submissions Lead II - Shape Global Trials

Premier Research International; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Premier Research seeks a Regulatory Submissions Lead II to drive regulatory strategy, submissions, and approvals across multiple regions, including EU CTIS and US IRB oversight. You will oversee start-up plans, manage regulatory content quality, and coordinate complex submissions for multi-region studies.

The role requires 8–10 years of regulatory submissions experience, with at least 6 years in a lead capacity, and a strong understanding of FDA/EU regulations, GMO, and product development

Qualifications

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• Hands-on experience with Part I and Part II submissions in CTIS and US IRB oversight experience is a must.
• 8-10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead or equivalent.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle by developing and managing regulatory and start-up project plans.
• Coordinate and submit Clinical Trial Applications (CTAs) to all applicable regulatory bodies, import/export licenses, and other regulatory applications for multi-region studies.
• For EU interventional studies, lead activities within CTIS and own the overall regulatory submission strategy
• Review essential regulatory documents to ensure compliance, completeness, quality, and country-specific requirements.
• Drive start-up readiness by defining Greenlight Package templates and supporting activation strategies with cross-functional teams.
• Maintain regulatory excellence, compliance, and financial oversight, monitoring budgets and identifying out-of-scope activities.
• Provide leadership and mentorship, coaching junior staff and contributing to business development through client interactions.

Skills

Regulatory strategy

Clinical trial submissions

CTIS experience

IRB oversight

Risk management

Cross-functional leadership

Education

University degree in pharmacy/medicine or related

Job description

Premier Research seeks a Regulatory Submissions Lead II to drive regulatory strategy, submissions, and approvals across multiple regions, including EU CTIS and US IRB oversight. You will oversee start-up plans, manage regulatory content quality, and coordinate complex submissions for multi-region studies.

The role requires 8–10 years of regulatory submissions experience, with at least 6 years in a lead capacity, and a strong understanding of FDA/EU regulations, GMO, and product development