Global Regulatory Submissions Lead II: Strategy & Start-Up

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

Job summary

Premier Research Group seeks a Regulatory Submissions Lead II to join its Regulatory Submissions and Contracts team. You will drive regulatory strategy, submissions, and approvals across multiple countries, coordinating CTAs, import/export licenses, and regulatory documentation for complex studies.

You will work with sponsors and project teams to align timelines, manage risks, and ensure document readiness while staying current with evolving regulations.

Qualifications

• Experience with Part I and Part II submissions in CTIS.
• Ability to lead regulatory and submission discussions with sponsors and teams.
• Strong understanding of regulatory requirements across regions.

Responsibilities

• Lead and execute regulatory strategy, submissions, and approvals across participating countries.
• Coordinate and submit CTAs to Ethics Committees, IRBs, and regulatory authorities.
• Prepare and review core submission documents (forms, letters, PIF/ICF, import/export apps).
• Review regulatory documents (IMPDS, protocols, IBs, country ICFs, product labels).
• Define Greenlight Package templates and support country/site activation strategies.
• Maintain compliance and oversight of regulatory activities and budgets; mentor junior staff.

Skills

Regulatory knowledge

ICH/GCP expertise

Cross-functional collaboration

Project management

Education

University degree in life sciences

Job description

Premier Research Group seeks a Regulatory Submissions Lead II to join its Regulatory Submissions and Contracts team. You will drive regulatory strategy, submissions, and approvals across multiple countries, coordinating CTAs, import/export licenses, and regulatory documentation for complex studies.

You will work with sponsors and project teams to align timelines, manage risks, and ensure document readiness while staying current with evolving regulations.