Global Regulatory Submissions Lead — Flexible

premierresearch; España; On-site; EUR 90,000 - 120,000; Full time

Job summary

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team in a pivotal regulatory role. You will drive submissions across countries, manage CTIS activities, and coordinate start-up plans for complex studies in multiple regions.

You will oversee document quality, timelines, and regulatory requirements, partnering with sponsors and cross-functional teams to ensure smooth progression from approval to site activation and ongoing compliance.

Qualifications

• University degree in pharmacy, medicine or related natural sciences.
• 8–10 years in regulatory roles with at least 6 as a lead.
• Experience in global regulatory submissions and CTIS is essential.

Responsibilities

• Lead regulatory strategy, submissions, and approvals across multiple regions.
• Prepare and review core submission documents and country packages.
• Coordinate start-up activities, greenlight packages, and site activation.
• Ensure compliance, quality, and timely regulatory deliverables.
• Manage risks, budgets, and cross-functional collaboration with sponsors.
• Provide leadership and mentorship to junior staff and support BD efforts.

Skills

Regulatory submissions

CTIS system

ICH/GCP regulations

FDA/EU regulations

Project management

Education

Pharmacy or related degree

Tools

CTIS tools

Job description

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team in a pivotal regulatory role. You will drive submissions across countries, manage CTIS activities, and coordinate start-up plans for complex studies in multiple regions.

You will oversee document quality, timelines, and regulatory requirements, partnering with sponsors and cross-functional teams to ensure smooth progression from approval to site activation and ongoing compliance.