Global Regulatory Submissions Lead

11 Premier Research International LLC; Argentina; On-site; ARS 138,487,000 - 200,037,000; Full time

Job summary

Premier Research International LLC is seeking a Regulatory Submissions Lead II to guide regulatory strategy, lead multi-region submissions, and ensure alignment across sponsors and project teams. The role spans EU, US, and ARG submission activities in a dynamic biotech, medtech, and pharma environment.

You will drive start-up activities, coordinate documentation and timelines, mentor junior staff, and contribute to business development while maintaining high quality standards and regulatory

Qualifications

• Bachelor level degree in pharmacy, medicine or related natural sciences.
• Experience with EU CTIS Part I submissions, US IRB oversight and Argentine submission processes.
• 8–10 years in regulatory submissions or related leadership roles.
• Strong knowledge of ICH/GCP and FDA/EU regulations and start-up procedures.

Responsibilities

• Lead regulatory strategy, submissions, and approvals across participating countries.
• Directly own EU CTIS Part I submissions and multi-country start-up activities.
• Coordinate submission packages, country-specific requirements, and timelines with sponsors and teams.
• Identify risks and drive regulatory discussions during kick-off meetings and calls.
• Mentor junior staff, coach teams, and contribute to business development activities.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Multitasking

Education

University degree in pharmacy, medicine, or related sciences

Job description

Premier Research International LLC is seeking a Regulatory Submissions Lead II to guide regulatory strategy, lead multi-region submissions, and ensure alignment across sponsors and project teams. The role spans EU, US, and ARG submission activities in a dynamic biotech, medtech, and pharma environment.

You will drive start-up activities, coordinate documentation and timelines, mentor junior staff, and contribute to business development while maintaining high quality standards and regulatory