Regulatory Submissions Lead II

Premier Research International; United States; Sur place; USD 120 000 - 170 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory strategy

Clinical trial submissions

CTIS experience

IRB oversight

Risk management

Cross-functional leadership

Formation

University degree in pharmacy/medicine or related

Description du poste

Premier Research is looking for a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

Your ideas influence the way we work, and your voice matters here.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You’ll Be Doing :

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; coordinating and submitting Clinical Trial Applications (CTAs) to all applicable regulatory bodies (Ethics Committee, Institutional Review Boards, Competent Authorities (CA, CEC/CIRB, LEC/LIRB)), import/export licenses, and other regulatory applications for multi-region and complex studies in start-up. For maintenance studies, ensures timely submission of substantial and non-substantial modifications, and all required trial notifications, including first patient in, end of trial, temporary halts and early terminations until Clinical Study Reports. For EU interventional clinical studies, directly lead and execute activities within the Clinical Trial Information System (CTIS), owning the development of the overall regulatory submission strategy as well as the preparation and completion of the Part I. Act as the primary regulatory & submissions lead for sponsors and project teams , ensuring alignment on timelines, deliverables, submission strategies, document readiness, and regulatory requirements. Proactively identify, communicate, and manage risks, issues, and contingency plans; escalat... Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents such as application forms, cover letters, Patient Information Sheets/Informed Consent Forms (PIF/ICF); import/export applications; country-specific submission packages. Review essential clinical and regulatory documents including IMPDs, protocols, Investigator's Brochures, master/country informed consent forms, investigational product labels, and other regulatory materials to ensure compliance, completeness, quality, and country-specific acceptability requirements. Drive start-up readiness by defining and agreeing Greenlight Package templates with sponsors, coordinating the completion of country and site greenlight packages with Study Start-Up Associates (SSUAs), and supporting overall country and site activation strategies in partnership with other functional areas to ensure efficient progression from regulatory approval to site activation. Maintain operational excellence, compliance, and financial oversight by ensuring high-quality execution of all regulatory and start-up activities, staying current with evolving regulations and guidance, supporting continuous process improvement initiatives, monitoring study start-up budgets and contractual obligations and identifying out-of-scope activities related to their functional area. Provide leadership, expertise, and business support by serving as a subject matter expert in specialized areas and complex studies such as GMO, MedTech, or other regulatory domains; coaching, mentoring, supervising, and training junior staff; leading departmental improvement initiatives; and contributing to business development activities through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development.

What We Are Searching For:

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, Start-Up Lead, Submissions Manager, or equivalent Experience in managing submission of complex trials, different IP types and different phases, globally Experience in MD/IVDR and GMO is highly recommended. Experience in Health Canada clinical trial submissions is highly recommended. Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable. Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start-up procedures. Excellent team p