Senior Regulatory Submissions Lead – Global Impact

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

Job summary

Premier Research is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead regulatory strategy, submissions, and approvals across regions, coordinating multi-country CTAs and start-up activities for complex studies.

You will review key regulatory documents, manage risks, and mentor junior staff while collaborating with sponsors and project teams to ensure timely, compliant submissions throughout the study lifecycle.

Qualifications

• Experience leading Part I and Part II CTIS submissions.
• 8–10 years in regulatory submissions; at least 6 years in lead roles.
• Experience managing complex trials globally and across IP types.
• Strong knowledge of ICH/GCP, FDA/EU regulations, ISO14155.
• Ability to lead, mentor, and coordinate multi-disciplinary teams.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across countries throughout the study lifecycle.
• Coordinate and submit CTAs to regulatory bodies, import/export licenses, and other regulatory applications.
• Ensure timely submission of modifications and trial notifications for maintenance studies.
• Own submission documentation and regulatory content quality for core documents.
• Review clinical/regulatory documents for compliance and country-specific requirements.
• Drive start-up readiness and activation strategies in partnership with cross-functional teams.

Skills

Regulatory submissions

Project management

Cross-functional collaboration

Regulatory risk management

CTIS experience

Education

University degree in pharmacy, medicine or related natural sciences

Tools

CTIS system

Regulatory databases

Job description

Premier Research is seeking a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team in Spain. You will lead regulatory strategy, submissions, and approvals across regions, coordinating multi-country CTAs and start-up activities for complex studies.

You will review key regulatory documents, manage risks, and mentor junior staff while collaborating with sponsors and project teams to ensure timely, compliant submissions throughout the study lifecycle.