Global Regulatory Submissions Lead

Premier Research Group; Argentina; On-site; ARS 138,487,000 - 230,812,000; Full time

Job summary

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma clients transform ideas into medicines, devices, and diagnostics, driving regulatory success across regions.

You will lead regulatory strategy, coordinate CTAs, ensure compliance with ICH/GCP and country-specific requirements, and support start-up readiness while mentoring junior staff and collaborating with sponsors to achieve

Qualifications

• University degree in pharmacy, medicine or related natural sciences is preferred.
• Hands-on experience with EU CTIS Part I submissions and US IRB oversight.
• Experience in Argentine submission processes is required.
• 8-10 years of regulatory submissions experience, including at least 6 years in lead roles.
• Knowledge of ICH/GCP regulations and FDA/EU regulatory guidance.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across all participating countries.
• Act as primary regulatory & submissions lead for sponsors and project teams.
• Own submission documentation and regulatory content quality.
• Drive start-up readiness and country/site activation strategies.
• Maintain compliance, process improvement, and budget oversight.
• Mentor and develop junior staff and contribute to business development.

Skills

Regulatory submissions

Project management

Cross-country coordination

Education

University degree in pharmacy/medicine or related natural sciences

Job description

Premier Research Group seeks a Regulatory Submissions Lead II to join our Regulatory Submissions and Contracts team. You will help biotech, medtech, and specialty pharma clients transform ideas into medicines, devices, and diagnostics, driving regulatory success across regions.

You will lead regulatory strategy, coordinate CTAs, ensure compliance with ICH/GCP and country-specific requirements, and support start-up readiness while mentoring junior staff and collaborating with sponsors to achieve