Regulatory Submissions Lead II

Premier Research Group; United States; Remote; USD 140,000 - 180,000; Full time

Job summary

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in the United States. The role focuses on guiding regulatory strategies, submissions, and approvals across regions for complex studies.

You will lead submission content quality, coordinate cross-country filings, and partner with sponsors to ensure timely regulatory success while supporting start-up readiness and governance. A strong background in EU and US regulations is preferred.

Qualifications

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• Hands-on experience with EU CTIS Part I submissions, US IRB oversight, and Argentine submission processes are a must.

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.
• Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines, deliverables, submission strategies, document readiness, and regulatory requirements.
• Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents and country-specific submission packages.
• Drive start-up readiness by defining Greenlight Package templates and coordinating country/site activation strategies.
• Maintain regulatory and start-up excellence, stay current with evolving regulations, and monitor study start-up budgets and obligations.

Skills

Regulatory submissions

Start-up coordination

CTIS Part I

FDA/EU regulations

Team leadership

Education

University degree in Pharmacy/Medicine/related natural sciences

Job description

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; escalate critical concerns; provide recommendations for resolution; and lead regulatory and submission-related discussions during kick-off meetings, and internal/external study calls.
• 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; and 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 sciencesare a plus)
• Hands‑on experience with EU CTIS Part I submissions, US IRB oversight, and expertise in Argentine submission processes are a must.
• 8-10years’ experience, including at least 6years’ experienceas Regulatory Submissions Lead, Start-Up Lead, Submissions Manager,or equivalent
• Experience in managing submission of complex trials, different IP types anddifferent phases, globally
• Experience in MD/IVDR and GMO is highly recommended.
• Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable.Excellentknowledge of FDA Guidance Documents/EURegulations/ISO14155 regulations, drug / device development, and start-up procedures.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Excellent organizationaland time-management skills, ableprioritizework to meet deadlines.
• Accountable,dependableand strong commitmentto quality.
• Customer service focused approach to work both internally and externally.