Senior Regulatory Submissions Lead

Premier Research

17h

About The Position

Premier Research is seeking a Senior Regulatory Submissions Lead for its Regulatory Submissions and Contracts team. The role leads regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle, with responsibility for complex, multi-region clinical studies and EU interventional studies using CTIS. The position serves as the primary regulatory and submissions lead for sponsors and project teams, overseeing timelines, deliverables, submission strategies, documentation quality, risks, and regulatory requirements. The role also drives country and site start-up readiness, supports compliance and process improvement, monitors budgets and contractual obligations, and provides subject-matter expertise for specialized or complex regulatory areas. It includes coaching and training junior staff, leading departmental improvement initiatives, and contributing regulatory expertise to business development activities. This is a freelance/contract position offered as a full FTE for up to six months. Hiring location is flexible.

Requirements

University-level education; pharmacy, medicine, or related natural sciences are a plus.
8–10 years of experience, including at least 6 years as a Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
Experience managing global submissions for complex trials, different investigational product types, and different phases.
Experience managing the CTIS system.
Excellent knowledge of ICH/GCP regulations and applicable country-specific regulations.
Excellent knowledge of FDA Guidance Documents, EU Regulations, ISO 14155 regulations, drug/device development, and start-up procedures.
Ability to work accurately and interpret relevant directives and guidelines.
Ability to meet objectives and complete projects within agreed budgets and timelines.
Collaborative team player with the ability 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 in work with internal and external stakeholders.

Nice To Haves

Background in pharmacy, medicine, or related natural sciences.
Availability at short notice and readiness to work as a freelancer or contractor.

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, import/export licenses, and other regulatory applications for multi-region and complex studies.
For maintenance studies, submit 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.
Act 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 and submission discussions at kick-off meetings and study calls.
Prepare, review, and secure sponsor approval of 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 country and site greenlight packages with Study Start-Up Associates.
Support country and site activation strategies in partnership with other functional areas.
Ensure high-quality execution of regulatory and start-up activities, 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, such as 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 regulatory input during proposal development.