Strategic Study Start-Up & Regulatory Expert

Ergomed; Madrid; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Ergomed is seeking a Study Start Up and Regulatory Affairs Specialist in Madrid to lead regulatory readiness for site initiation, ensure ICH-GCP compliance, and liaise with internal teams, clients and external stakeholders. The role requires at least 2 years in pharma/CRO, a life sciences graduate degree, and the ability to draft/review regulatory documents, translations and site agreements.

You will develop regulatory strategy, manage timelines, identify risks, and drive submissions across

Formación

• Graduate degree in life sciences or nursing.
• At least 2 years in pharma/CRO or regulatory body.
• Solid knowledge of ICH GCP and national regulations.
• Experience with SSU/regulatory delivery in Europe and/or the Americas.

Responsabilidades

• Deliver and manage start-up and regulatory milestones.
• Develop regulatory strategy and SSU plan.
• Draft, negotiate and execute site and ancillary agreements.
• Review labels, patient information sheets, diaries, and other docs for compliance.
• Coordinate translations of essential documents.
• Identify risks and support corrective/preventive actions.
• Provide regulatory input to internal and external customers.
• Lead SSU activities for assigned countries/projects.
• Perform other duties as needed.

Conocimientos

Regulatory compliance

SSU / regulatory strategy

Cross-functional liaison

Risk management

Documentation quality control

Educación

Graduate degree in Chemistry or Life Sciences, Nursing or equivalent

Descripción del empleo

Ergomed is seeking a Study Start Up and Regulatory Affairs Specialist in Madrid to lead regulatory readiness for site initiation, ensure ICH-GCP compliance, and liaise with internal teams, clients and external stakeholders. The role requires at least 2 years in pharma/CRO, a life sciences graduate degree, and the ability to draft/review regulatory documents, translations and site agreements.

You will develop regulatory strategy, manage timelines, identify risks, and drive submissions across