Senior Regulatory Submissions Lead

Senior Regulatory Submissions Lead

Join a mission-driven team transforming life-changing ideas into medical innovations that save and improve lives. As a Senior Regulatory Submissions Lead, you will play a pivotal role in shaping the future of healthcare by guiding complex clinical trial submissions across multiple regions, ensuring compliance, and supporting groundbreaking research.

Overview

In this role, you’ll lead and execute regulatory strategies for clinical studies, overseeing submission processes from start-up through approval. You’ll be the go-to expert for CTIS and other regulatory platforms, working closely with sponsors and cross-functional teams to drive efficient study initiation and maintenance. If you’re passionate about regulatory science, thrive in dynamic environments, and want to contribute to meaningful advancements, this is your opportunity.

Key Responsibilities

• Develop and manage regulatory and start-up plans, including Clinical Trial Applications (CTAs), import/export licenses, and other submissions across multiple countries.
• Lead activities within CTIS for EU interventional studies, managing Part I submissions and ensuring compliance with evolving regulations like Regulation 536/2014.
• Serve as the primary regulatory contact for sponsors, fostering trust through clear communication on timelines, deliverables, and compliance requirements.
• Prepare, review, and approve documentation such as application forms, informed consent forms, and country-specific packages, ensuring quality and regulatory adherence.
• Drive start-up readiness by coordinating with Study Start-Up Associates, defining templates, and supporting site activation strategies.
• Oversee operational excellence by monitoring compliance, staying current with regulations, and supporting process improvements.
• Provide expert guidance and mentorship within the team, contributing to departmental growth and client success.

Must-Have Requirements

• 8-10 years’ experience in regulatory submissions, including at least 6 years as a Lead or Manager roles managing complex global trials.
• Proven experience managing CTIS submissions and cross-country registration activities.
• Strong knowledge of ICH/GCP, FDA, EU regulations, and related guidelines.
• Bachelor’s degree in a related field (e.g., pharmacy, medicine, sciences).
• Excellent organizational skills, attention to detail, and ability to work efficiently under pressure.
• Strong collaborator with excellent communication skills and a customer-focused mindset.

Nice-to-Have Skills

• Experience with managing submissions of diverse IP types and different trial phases.
• Knowledge of additional regulatory domains such as GMO or MedTech.
• Experience coaching and mentoring junior staff.

This is a contract role with a flexible, remote location within Europe, ideal for those seeking to make a meaningful impact in the healthcare industry.