Global SSU & Regulatory Lead

Ergomed; Comunidad de Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

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

Responsibilities include delivering study start-up and regulatory milestones, drafting and reviewing essential documents, translations, and negotiating site agreements; you

Formación

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Minimum 4 years within pharmaceutical or CRO industry.
• Good knowledge of ICH GCP and national regulations.
• Good understanding of SSU/Regulatory delivery across multiple countries in Europe/Americas.

Responsabilidades

• Lead and coordinate study start-up and regulatory milestones within defined scope.
• Prepare, review, and QC regulatory and SSU documentation to ensure accuracy.
• Draft and finalize clinical site agreements and amendments at country/regional level.
• Review labels, patient information sheets, and insurance for compliance.
• Provide regulatory strategy input and develop SSU plans and SOPs.

Conocimientos

Regulatory expertise

Educación

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

Descripción del empleo

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

Responsibilities include delivering study start-up and regulatory milestones, drafting and reviewing essential documents, translations, and negotiating site agreements; you