Senior Regulatory Submissions Lead

Premier Research•Regional_TX, TX

About The Position

Premier Research is hiring a Senior Regulatory Submissions Lead for its Regulatory Submissions and Contracts team. The role supports biotech, medtech, and specialty pharma organizations in developing medicines, devices, and diagnostics. The lead owns regulatory strategy and submission execution across participating countries throughout the study lifecycle, serving as the primary regulatory and submissions contact for sponsors and project teams. The position also oversees submission documentation quality, start-up readiness, operational compliance and financial oversight, and provides subject-matter expertise, staff mentorship, departmental leadership, and business-development support.

Requirements

University-level education; pharmacy, medicine, or related natural sciences are a plus.
Hands-on experience with Part I and Part II submissions in CTIS.
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 globally, across different investigational product types and development phases.
Excellent knowledge of ICH/GCP and applicable country-specific regulations.
Excellent knowledge of FDA guidance documents, EU regulations, ISO 14155 regulations, 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.

Responsibilities

Lead regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle, including 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, as well as import/export licenses and other applications for multi-region and complex studies.
For maintenance studies, ensure timely submission of substantial and non-substantial modifications and required trial notifications, including first patient in, end of trial, temporary halts, and early terminations through Clinical Study Reports.
For EU interventional clinical studies, lead activities in CTIS, own the overall regulatory submission strategy, and prepare and complete Part I.
Serve as the primary regulatory and submissions lead for sponsors and project teams, aligning timelines, deliverables, submission strategies, document readiness, and regulatory requirements.
Identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns; recommend resolutions; and lead regulatory discussions at 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; coordinate completion of country and site greenlight packages with Study Start-Up Associates; and support country and site activation strategies with other functional areas.
Ensure high-quality execution of regulatory and start-up activities, keep current with regulations and guidance, support process improvement, monitor study start-up budgets and contractual obligations, and identify out-of-scope activities.
Serve as a subject-matter expert in specialized areas and complex studies, such as GMO and MedTech; coach, mentor, supervise, and train junior staff; lead departmental improvement initiatives; and support business development through client meetings, bid defenses, presentations, and proposal development.