Experteer Overview
In this role you lead regulatory strategy and submissions across multiple regions, driving approvals throughout the study lifecycle. You will own CTAs and regulatory documents, coordinate with cross-functional teams, and ensure alignment on timelines and compliance. You’ll guide start-up readiness and submission quality, while mentoring junior staff and contributing to business development. This position offers impact on patient access to innovative therapies and flexible, project-based work with potential for internal growth.

Compensaciones / Beneficios
• Lead regulatory strategy, submissions and approvals across participating countries during the study lifecycle, including CTAs, import/export licenses, and multi-region studies
• Own and coordinate submission documentation quality and sponsor approvals for core materials (forms, PIF/ICF, country submissions)
• Review essential regulatory documents (IMPDs, protocols, ICH/GCP/regulatory materials) for compliance and country-specific requirements
• Drive start-up readiness by defining Greenlight templates and coordinating site activation in partnership with SSUAs and other functions
• Provide leadership and SME input on complex studies (GMO, MedTech) and mentor junior staff
• Lead regulatory discussions in kick-offs and study calls, identify risks,



and propose resolution strategies
• Support business development activities through client meetings, bid defenses, and regulatory input during proposals
• Maintain operational excellence by staying updated on evolving regulations and monitoring budgets and contractual obligations

Responsabilidades
• 8-10 years of experience in regulatory submissions roles, including at least 6 years as a regulatory submissions lead or equivalent
• Experience managing submission of complex trials globally and across IP types and phases
• Proficiency with CTIS system and knowledge of ICH/GCP and country-specific regulations
• Strong understanding of FDA/EU regulations, ISO14155, and drug/device development and start-up procedures
• Ability to interpret directives and manage objectives within budgets and timelines
• Collaborative team player with excellent organizational and time-management skills
• Customer service oriented with ability to work in fast-paced, changing environments
• Freelance/contract to full-time availability and flexibility in hiring location

Requisitos principales
• adaptable work arrangement
• potential freelance-to-FTE trajectory
• opportunity to influence global regulatory strategy

📌 Senior Regulatory Submissions Lead (España)
🏢 Premier Research
📍 España