Global Regulatory Submissions Lead — Start-up & Strategy

Premier Research Group; España; On-site; EUR 90,000 - 120,000; Full time

Job summary

Premier Research Group is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead and execute regulatory strategy, submissions, and approvals across multiple regions, coordinating CTAs, imports/exports, and complex regulatory packages for multi-region studies.

You will act as the primary submissions lead for sponsors and project teams, shaping submission timelines, ensuring document readiness, and guiding junior staff, while staying

Qualifications

• Experience leading regulatory submissions for CTIS Part I/II.
• Strong knowledge of ICH/GCP and EU regulations (MDR/IVDR) and country-specific rules.
• Ability to manage multi-region submissions and complex study types.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across regions.
• Coordinate CTAs, import/export licenses, and regulatory applications for multi-region studies.
• Ensure timeliness of submissions and document readiness; manage risk and issues.
• Coach junior staff and contribute to business development through proposing regulatory input.

Skills

Regulatory leadership

Cross-functional collaboration

Project coordination

Stakeholder management

Regulatory strategy

Education

University degree in pharmacy/medicine or related natural sciences

Tools

CTIS

Job description

Premier Research Group is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead and execute regulatory strategy, submissions, and approvals across multiple regions, coordinating CTAs, imports/exports, and complex regulatory packages for multi-region studies.

You will act as the primary submissions lead for sponsors and project teams, shaping submission timelines, ensuring document readiness, and guiding junior staff, while staying