Global Regulatory Submissions Lead — Contract, Flexible Location

Premier Research Group; España; A distancia; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

Premier Research Group seeks a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, submissions, and approvals across multiple regions, coordinating CTAs and regulatory packages for biotech, medtech, and specialty pharma studies.

You will act as primary regulatory lead, ensure document quality, manage risks and timelines, and drive start-up readiness while mentoring junior staff.

Formación

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• 8-10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
• Experience in managing submission of complex trials, different IP types and different phases, globally.
• Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable.
• Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug / device development, and start-up procedures.

Responsabilidades

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle.
• Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines and regulatory requirements.
• Own submission documentation and regulatory content quality, review essential clinical and regulatory documents.
• Drive start-up readiness and country/site activation strategies in partnership with other functions.
• Maintain operational excellence, compliance, and financial oversight of regulatory start-up activities.

Educación

University degree level (pharmacy, medicine or related natural sciences)

Herramientas

CTIS system

Descripción del empleo

Premier Research Group seeks a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead regulatory strategy, submissions, and approvals across multiple regions, coordinating CTAs and regulatory packages for biotech, medtech, and specialty pharma studies.

You will act as primary regulatory lead, ensure document quality, manage risks and timelines, and drive start-up readiness while mentoring junior staff.