Global Study Start-Up & Regulatory Lead

ERGOMED; Madrid; Presencial; EUR 42.000 - 68.000; Jornada completa

Descripción de la vacante

Ergomed, a specialist clinical research organisation, is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate study start up and regulatory activities across multiple countries, ensuring regulatory compliance and timely site initiation.

You will draft and review essential documents, manage country-specific regulatory submissions, translations, and agreements, and provide strategic input to clients and internal teams to protect timelines and data quality.

Formación

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• Minimum 2 years within pharmaceutical or CRO industry or Regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency

Responsabilidades

• Lead study start-up and regulatory activities for assigned countries or projects of medium complexity, ensuring delivery in line with timelines, quality standards, and regulatory requirements.
• Prepare, review, and quality control regulatory and study start-up documentation (submissions, essential documents, translations) to ensure completeness and compliance with ICH-GCP and country-specific requirements.
• Draft, negotiate, finalize, and execute clinical site agreements and ancillary agreements at country or regional level within project timelines
• Review labels, patient information sheets, diary cards, and insurance to ensure compliance with ICH GCP and country-specific requirements
• Provide regulatory/SSU strategic input to internal and external customers; develop regulatory strategy and SSU plan, SOPs, and core documents
• Identify and escalate risk to the project team and support corrective/preventive actions

Conocimientos

Regulatory knowledge

SSU/Regulatory delivery

ICH GCP knowledge

Educación

Bachelor's degree in Chemistry or Life Sciences, Nursing or equivalent

Descripción del empleo

Ergomed, a specialist clinical research organisation, is seeking a Specialist, Study Start Up and Regulatory Affairs to lead and coordinate study start up and regulatory activities across multiple countries, ensuring regulatory compliance and timely site initiation.

You will draft and review essential documents, manage country-specific regulatory submissions, translations, and agreements, and provide strategic input to clients and internal teams to protect timelines and data quality.