SSU & Regulatory Affairs Specialist for Rare Disease

Ergomed; España; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Ergomed, a specialist CRO, seeks a Senior regulatory professional to lead study start-up and regulatory activities across multi-country trials. You will ensure compliance with ICH-GCP and country requirements, draft and negotiate essential agreements, and coordinate with internal teams and external stakeholders.

The role emphasizes strategic input on SSU plans, risk management, and timely delivery of milestones in complex regulatory environments.

Formación

• Regulatory and SSU expertise required for complex trials.
• ICH-GCP and country-specific regulatory knowledge essential.
• Experience with multi-country regulatory submissions beneficial.

Responsabilidades

• Lead study start-up and regulatory milestones within defined scope.
• Make independent decisions on regulatory processes and documentation approaches.
• Handle medium-complexity regulatory environments, including multi-country requirements.
• Lead start-up and regulatory activities for assigned countries/projects with timelines and quality standards.
• Oversee drafting, negotiating, and executing clinical site and ancillary agreements.
• Review essential documents to ensure compliance with ICH-GCP and country requirements.
• Contribute to preparation/review of complex technical/scientific/legal documentation.
• Arrange translations of essential documents as required.
• Provide regulatory/SSU strategic input; develop regulatory strategy and SSU Plan.
• Identify and escalate risks to the project team, supporting corrective actions.
• Perform other duties as assigned.

Conocimientos

Regulatory Affairs

SSU

ICH-GCP

Multi-country

Clinical trials

Educación

Graduate degree in Chemistry or Life Sciences

Experience in pharmaceutical or CRO industry

Knowledge of ICH-GCP and national regulations

Country requirements for SSU/regulatory delivery

Descripción del empleo

Ergomed, a specialist CRO, seeks a Senior regulatory professional to lead study start-up and regulatory activities across multi-country trials. You will ensure compliance with ICH-GCP and country requirements, draft and negotiate essential agreements, and coordinate with internal teams and external stakeholders.

The role emphasizes strategic input on SSU plans, risk management, and timely delivery of milestones in complex regulatory environments.