Regulatory Submissions Lead II

Premier Research•Regional_NC, NC

About The Position

Premier Research is seeking a Regulatory Submissions Lead II to join its Regulatory Submissions and Contracts team. The role supports biotech, medtech, and specialty pharma companies in bringing medicines, devices, and diagnostics to patients. The lead manages regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle. This includes developing regulatory and start-up plans; coordinating submissions to ethics committees, institutional review boards, competent authorities, and other bodies; managing import/export licenses and trial notifications; and leading relevant EU clinical trial activities in CTIS, including overall submission strategy and preparation and completion of Part I. Serving as the primary regulatory and submissions lead for sponsors and project teams, this role aligns timelines, deliverables, strategies, documentation, and regulatory requirements; manages risks and issues; and leads regulatory discussions. The role also owns submission documentation quality, supports country and site start-up readiness, monitors operational and financial obligations, and contributes regulatory expertise, staff development, departmental improvements, and business development.

Requirements

University degree; pharmacy, medicine, or related natural sciences are a plus.
Hands-on experience with CTIS Part I and Part II submissions.
US IRB oversight experience.
8–10 years of experience, including at least 6 years as a Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
Experience managing submissions for complex trials, different investigational product types, and different phases globally.
Excellent knowledge of ICH/GCP and applicable country-specific regulations.
Excellent knowledge of FDA guidance documents, EU regulations, ISO 14155, drug and device development, and start-up procedures.
Collaborative team player able to build an effective team.
Ability to multitask and work effectively in a fast-paced environment with changing priorities.
Excellent organizational and time-management skills, including the ability to prioritize work and meet deadlines.
Accountable and dependable, with a strong commitment to quality.
Customer-service-focused approach to internal and external work.

Nice To Haves

Experience in MD/IVDR and GMO.
Experience with Health Canada clinical trial submissions.
Pharmacy, medicine, or related natural sciences degree.

Responsibilities

Lead and execute regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle.
Develop and manage regulatory and start-up project plans.
Coordinate and submit Clinical Trial Applications to applicable ethics committees, institutional review boards, competent authorities, and other regulatory bodies for multi-region and complex studies.
Manage import/export licenses and other regulatory applications.
For maintenance studies, submit substantial and non-substantial modifications and required trial notifications, including first-patient-in, end-of-trial, temporary-halt, and early-termination notifications through Clinical Study Reports.
For EU interventional clinical studies, lead CTIS activities, own the overall regulatory submission strategy, and prepare and complete Part I.
Act as primary regulatory and submissions lead for sponsors and project teams, aligning timelines, deliverables, strategies, document readiness, and regulatory requirements.
Identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns and recommend resolutions.
Lead regulatory and submission discussions during kick-off meetings and internal and external study calls.
Prepare, review, and obtain sponsor approval for core submission documents, including application forms, cover letters, Patient Information Sheets/Informed Consent Forms, import/export applications, and country-specific submission packages.
Review essential clinical and regulatory documents, including IMPDs, protocols, Investigator's Brochures, informed consent forms, investigational product labels, and other regulatory materials for compliance, completeness, quality, and country-specific acceptability.
Define and agree Greenlight Package templates with sponsors and coordinate completion of country and site greenlight packages with Study Start-Up Associates.
Support country and site activation strategies with other functional areas to progress from regulatory approval to site activation.
Ensure high-quality regulatory and start-up execution, stay current with regulations and guidance, and support continuous process improvement.
Monitor study start-up budgets and contractual obligations and identify out-of-scope activities within the functional area.
Serve as a subject matter expert in specialized areas and complex studies, including GMO and MedTech.
Coach, mentor, supervise, and train junior staff.
Lead departmental improvement initiatives.
Contribute to business development through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development.