Global Study Start-Up & Regulatory Lead

Ergomed; Lazio; In loco; EUR 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Ergomed is seeking a Senior Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities ensuring site initiation readiness. You will provide expertise, ensure regulatory compliance, and act as a key liaison between internal teams, clients, and external stakeholders.

Responsibilities include managing regulatory milestones, preparing essential documents, and coordinating across countries to deliver timely, compliant SSU activities in complex trials.

Competenze

• Good knowledge of ICH GCP and national regulations for territories of competency.
• Experience leading study start-up and regulatory activities.
• Ability to work across multiple countries and projects.

Mansioni

• Leads and coordinates all activities related to achieving site initiation readiness.
• Provides regulatory subject matter expertise and liaises between internal teams, clients, and external stakeholders.
• Manages regulatory milestones within defined scope and timelines.
• Prepares, reviews, and quality-controls regulatory documents and submissions.
• Drafts and negotiates site-related agreements and amendments at country or regional level.
• Reviews documentation such as labels and patient information sheets for compliance.
• Develops regulatory strategy and SSU plans; elevates project risks when needed.
• Contributes to translation planning and ensures regulatory documentation meets ICH-GCP standards.

Conoscenze

Regulatory affairs

SSU leadership

ICH-GCP knowledge

Formazione

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience

Descrizione del lavoro

Ergomed is seeking a Senior Specialist, Study Start Up and Regulatory Affairs to lead and coordinate all activities ensuring site initiation readiness. You will provide expertise, ensure regulatory compliance, and act as a key liaison between internal teams, clients, and external stakeholders.

Responsibilities include managing regulatory milestones, preparing essential documents, and coordinating across countries to deliver timely, compliant SSU activities in complex trials.