Senior Regulatory Submissions Lead

Stellenbeschreibung:

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