Regulatory Submissions Lead II

Premier Research

. Lead and execute regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle .

Posted 10/26/2026full-timeRemote • Spain, Hungary, Bulgaria, Romania, PortugalSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory strategy and submissions management, with a strong focus on compliance with ICH/GCP regulations and FDA Guidance Documents. Proven ability to lead complex clinical trial submissions and coordinate cross-functional teams to ensure timely and high-quality execution.

Highest-signal resume keywords

Regulatory Submissions Lead ExperienceCTIS Submission ManagementKnowledge of ICH/GCP RegulationsExperience in MD/IVDR and GMOProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentClinical Trial Application SubmissionSubmission Document PreparationRisk ManagementBudget MonitoringRegulatory Compliance ReviewSubmission Strategy AlignmentProject PlanningGMO KnowledgeMedTech Experience

Soft Skills

Team CollaborationMultitaskingOrganizational SkillsAccountabilityCustomer Service Focus

Tools & Technologies

CTISSubmission Management Systems

Industry Keywords

Clinical TrialsRegulatory AffairsFDA RegulationsEU RegulationsISO 14155Drug DevelopmentDevice DevelopmentStart-Up Procedures

About the role

Key responsibilities & impact

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 regulatory bodies, import/export licenses, and other regulatory applications
Submit substantial and non-substantial modifications and required trial notifications for maintenance studies
Lead and execute EU interventional clinical study activities in CTIS, including overall submission strategy and Part I preparation and completion
Act as primary regulatory and submissions lead for sponsors and project teams
Align timelines, deliverables, submission 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/external study calls
Prepare, review, and secure sponsor approval of core submission documents and country-specific submission packages
Review clinical and regulatory documents for compliance, completeness, quality, and country-specific acceptability
Define Greenlight Package templates and coordinate country and site greenlight packages with Study Start-Up Associates
Support country and site activation strategies with other functional areas
Ensure high-quality, compliant regulatory and start-up execution
Monitor study start-up budgets and contractual obligations and identify out-of-scope activities
Serve as subject matter expert for 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

Requirements

What you’ll need

Education to university degree level
Hands-on experience with Part I and Part II submissions in CTIS
8–10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent
Experience managing submissions for complex trials, different IP types, and different phases globally
Experience in MD/IVDR and GMO highly recommended
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 collaborate and build an effective team
Ability to multitask effectively in a fast-paced environment with changing priorities
Excellent organizational and time-management skills; ability to prioritize work and meet deadlines
Accountability, dependability, and strong commitment to quality
Customer-service-focused approach for internal and external work

Benefits

Comp & perks

Flexibility and balance to support your life
Skills and opportunities for professional growth
Coaching, mentoring, supervision, and training opportunities
Participation in departmental improvement initiatives
Contribution to business development activities