Overview
In this role you drive regulatory strategy and submissions for multi-region studies, coordinating CTAs, regulatory applications, and trial milestones. You will lead cross-functional teams to ensure compliant, timely submissions and smooth study startup across EU and global contexts. You’ll own the CTIS process for EU trials and provide expert guidance on regulatory requirements. This position offers impact in delivering medical innovations that improve patient outcomes, with a focus on evolving regulations, process improvement, and leadership across projects.
Verantwortungsbereiche
- Lead regulatory strategy, submissions, and approvals across multiple countries throughout the study lifecycle, including CTAs and regulatory filings
- Serve as primary regulatory & submissions lead for sponsors and project teams, aligning timelines and deliverables
- Own submission documentation and regulatory content quality, reviewing core submission materials and country-specific packages
- Drive start-up readiness through Greenlight Package templates, site activation, and cross-functional coordination
- Maintain compliance, monitor budgets, and identify out-of-scope activities in regulatory start-up
- Provide leadership and SME support in specialized areas (GMO, MedTech) and mentor junior staff
Zentrale Anforderungen
- University degree level education; preferably in pharmacy, medicine or related natural sciences
- 8-10 years of experience in regulatory submissions and start-up roles, with at least 6 years in a lead capacity
- Experience managing submissions for complex, multi-region trials and different IP types
- Excellent knowledge of CTIS, ICH/GCP, FDA/EU regulations, ISO14155, and start-up procedures
- Ability to interpret directives and meet project timelines within budget
- Strong teamwork, collaboration, and ability to lead cross-functional teams
- Excellent organizational and time-management skills; customer service oriented
- collaborative
- strong time-management
- attention to detail
- CTIS system management
- Regulatory submissions documentation
- IMPDS and Investigator's Brochures review
Senior Regulatory Submissions Lead in Mönchengladbach Arbeitgeber: Premier Research
Premier Research ist ein hervorragender Arbeitgeber, der sich leidenschaftlich dafür einsetzt, das Leben von Patienten durch medizinische Innovationen zu verbessern. Mit einem starken Fokus auf Mitarbeiterentwicklung und einer flexiblen Arbeitskultur bieten wir Ihnen die Möglichkeit, Ihre Fähigkeiten in einem dynamischen Umfeld zu entfalten. Unsere umfassenden Sozialleistungen und die Möglichkeit zur beruflichen Weiterentwicklung machen uns zu einem attraktiven Arbeitsplatz für Fachkräfte im Bereich Dermatologie.
