Overview

As Regulatory Submissions Lead II, you steer global regulatory strategy and submissions across studies to secure approvals for novel therapies and devices. You’ll partner with cross-functional teams to manage CTAs, regulatory documents, and start-up activities, ensuring alignment with timelines and country requirements. You’ll own submission quality and regulatory content, anticipate risks, and contribute to business development through regulatory input. This role places you at the core of medical innovation, guiding complex projects from start-up to approval.

Responsabilidades

- Lead regulatory strategy and submissions across multiple regions for complex studies
- Coordinate and submit CTAs and regulatory applications, including ethics and competent authorities
- Own EU CTIS activities and develop overall submission strategy for Part I
- Prepare and secure approval of core submission documents (forms, cover letters, PIF/ICF)
- Review regulatory documents (IMPDS, ICH, IBs, consent forms, labels) for compliance and quality




- Drive start-up readiness, define Greenlight templates, and coordinate site activation
- Ensure regulatory excellence, budget oversight, and process improvement
- Provide senior-level expertise, coaching, and leadership across regulatory domains

Requisitos principales

- 8-10 years in regulatory submissions or related roles
- at least 6 years in a lead/submissions management capacity
- experience with complex trials and integral submissions
- experience with MD/IVDR and GMO is highly recommended
- excellent knowledge of ICH/GCP, FDA/EU regulations, ISO14155
- strong team collaboration, multitasking, and deadline-driven organization
- customer service oriented and accountable for quality

- team player
- collaborative
- strong communication
- CTIS hands-on experience
- regulatory submissions management
- start-up readiness and Greenlight processes

📌 Regulatory Submissions Lead II - españa
🏢 Premier Research
📍 España