Global Study Start-Up & Regulatory Affairs Lead

ERGOMED; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs in Lisbon to lead regulatory activities and ensure site initiation readiness across assigned projects.

You will coordinate with internal teams, clients, and external stakeholders, draft and review regulatory docs, translate where needed, and contribute to regulatory strategy aligned with ICH-GCP and country requirements.

Qualificações

• 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.
• Good understanding of specific country requirements pertaining to SSU/Regulatory delivery in multiple countries within Europe and/or the Americas.

Responsabilidades

• Lead and coordinate activities to achieve site initiation readiness within defined scope.
• Make independent decisions regarding regulatory processes and documentation approaches.
• Handle medium-complexity regulatory environments, including multi-country requirements where applicable.
• 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.
• Draft, negotiate, finalize, and execute clinical site agreements and amendments at country or regional level.
• Review labels, patient information sheets, diary cards, insurance, etc., for compliance with ICH GCP & country-specific requirements.
• Contribute to preparation/review of complex technical/scientific/legal documentation.
• Arrange for and/or review translation of essential documents as required.
• Provide regulatory/SSU strategic input, develop the regulatory strategy and SSU Plan, SOPs and core documents.
• Identify and elevate risks to the project team and support CAPA actions.
• Perform other work-related duties as assigned.

Formação académica

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

Descrição da oferta de emprego

Ergomed is seeking a Specialist, Study Start Up and Regulatory Affairs in Lisbon to lead regulatory activities and ensure site initiation readiness across assigned projects.

You will coordinate with internal teams, clients, and external stakeholders, draft and review regulatory docs, translate where needed, and contribute to regulatory strategy aligned with ICH-GCP and country requirements.