Senior Specialist, Study Start-Up & Regulatory Affairs

Ergomed Group; Lisboa; Presencial; EUR 55 000 - 75 000; Tempo integral

Resumo da oferta

Ergomed Group in Lisbon is seeking a Senior Specialist, Study Start Up and Regulatory Affairs to lead and coordinate activities to achieve site initiation readiness. You will provide regulatory expertise and ensure ICH-GCP compliance while serving as a key liaison between internal teams, clients and external stakeholders.

Responsibilities include delivering SSU/regulatory milestones, drafting and reviewing regulatory documents and site agreements, coordinating translations, and shaping

Qualificações

• Graduate degree in Chemistry or Life Sciences required.
• Minimum 4 years within pharmaceutical or CRO industry or regulatory body.
• Good knowledge of ICH GCP and national regulations for territories of competency.
• Understanding 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 a key liaison between internal teams, clients, and external stakeholders.
• Draft, negotiate, finalize, and execute regulatory documents and site agreements.
• Review essential documentation to ensure compliance with ICH GCP and country requirements.
• Develop regulatory strategy and SSU Plan; identify risks and implement corrective actions.

Conhecimentos

Regulatory affairs

Project coordination

ICH GCP knowledge

Communication

Formação académica

Graduate degree in Chemistry or Life Sciences

Nursing or equivalent combination of education and experience

Descrição da oferta de emprego

Ergomed Group in Lisbon is seeking a Senior Specialist, Study Start Up and Regulatory Affairs to lead and coordinate activities to achieve site initiation readiness. You will provide regulatory expertise and ensure ICH-GCP compliance while serving as a key liaison between internal teams, clients and external stakeholders.

Responsibilities include delivering SSU/regulatory milestones, drafting and reviewing regulatory documents and site agreements, coordinating translations, and shaping