Impactful Study Start-Up & Regulatory Lead

Ergomed; España; Presencial; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

Ergomed Group is a specialist clinical research organization focused on rare disease and select oncology indications, with global presence and a collaborative culture. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness and regulatory compliance.

Role requires a graduate degree in Chemistry/Life Sciences or Nursing, plus at least 2 years in pharma/CRO or regulatory bodies, and strong knowledge of ICH‑GCP and

Formación

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent.
• Minimum 2 years within pharmaceutical or CRO industry or Regulatory body.
• Good knowledge of ICH GCP and national regulations.
• Good understanding of country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas.

Responsabilidades

• Lead and coordinate all activities related to achieving site initiation readiness.
• Provide regulatory/SSU subject-matter expertise and ensure regulatory compliance.
• Serve as liaison between internal teams, clients and external stakeholders.
• Draft, negotiate and finalize site agreements and amendments.
• Prepare, review and quality control regulatory and SSU documentation (submissions, essential documents, translations).
• Identify and elevate risks to the project team and support corrective actions.
• Contribute to regulatory strategy, SSU plan and core documents.

Conocimientos

Regulatory affairs

Study start-up

ICH-GCP knowledge

SSU knowledge

Educación

Chemistry/Life sciences degree

Nursing degree

Descripción del empleo

Ergomed Group is a specialist clinical research organization focused on rare disease and select oncology indications, with global presence and a collaborative culture. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness and regulatory compliance.

Role requires a graduate degree in Chemistry/Life Sciences or Nursing, plus at least 2 years in pharma/CRO or regulatory bodies, and strong knowledge of ICH‑GCP and