OverviewAs Regulatory Submissions Lead II, you steer integral 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.

ResponsabilidadesLead 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 principales8-10 years in regulatory submissions or related roles at least 6 years in a lead/submissions management capacity experience with complex trials and global submissions experience with MD/IVDR and GMO is highly recommended excellent knowledge of ICH/GCP, FDA/EU regulations, ISO*

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 (Valladolid)
🏢 Premier Research
📍 Valladolid