Global Regulatory Submissions Lead — Contract

Premier Research; España; On-site; PHP 7,524,000 - 11,285,000; Full time

Job summary

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead and execute regulatory strategy, submissions, and approvals across participating countries, managing CTAs, import/export licenses, and complex studies in start-up and maintenance phases.

You will own submission documentation, review essential regulatory documents, ensure compliance with ICH/GCP and EU/FDA guidelines, drive start-up readiness, and mentor junior

Qualifications

• University degree in pharmacy, medicine, or related natural sciences.
• 8-10 years of regulatory submissions experience, including at least 6 years in lead roles.
• Experience managing CTIS submissions and global regulatory requirements (FDA EU).

Responsibilities

• Lead regulatory strategy, submissions, and approvals across participating countries.
• Own submission documents and ensure content quality and sponsor approval.
• Review essential regulatory documents for compliance and country-specific requirements.
• Drive start-up readiness and country/site activation strategies with cross-functional teams.

Skills

Regulatory leadership

CTIS knowledge

Regulatory strategy

Global submissions

Education

University degree in pharmacy/medicine or natural sciences

Tools

CTIS

Job description

Premier Research is seeking a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team. You will lead and execute regulatory strategy, submissions, and approvals across participating countries, managing CTAs, import/export licenses, and complex studies in start-up and maintenance phases.

You will own submission documentation, review essential regulatory documents, ensure compliance with ICH/GCP and EU/FDA guidelines, drive start-up readiness, and mentor junior