Strategic Study Start-Up & Regulatory Affairs Specialist

SmartRecruiters, Inc.; Lisboa; Híbrido; EUR 42 000 - 64 000; Tempo integral

Resumo da oferta

Ergomed Group seeks a Study Start Up and Regulatory Affairs Specialist to lead and coordinate activities ensuring site initiation readiness while ensuring regulatory compliance. The role serves as a key liaison between internal teams, clients, and external stakeholders across multiple jurisdictions.

The ideal candidate has a graduate degree in life sciences and experience in pharmaceutical/CRO environments with strong ICH-GCP knowledge.

Qualificações

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

Responsabilidades

• Lead and coordinate all activities related to achieving site initiation readiness.
• Provide regulatory/SSU subject matter expertise and act as liaison between internal teams, clients and external stakeholders.
• Deliver study start-up and regulatory milestones within defined scope and timelines.
• Draft, review and quality-control regulatory documents, submissions and essential documents.
• Negotiate and execute site agreements and ancillary agreements at country or regional level.
• Review labels, patient information sheets, diary cards and insurance to ensure compliance with ICH-GCP and country requirements.
• Develop regulatory strategy and SSU Plan; provide strategic input to internal and external customers.
• Identify and escalate risks to project timelines and support corrective actions.

Conhecimentos

Regulatory knowledge

SSU processes

ICH-GCP knowledge

Formação académica

Life sciences degree

Descrição da oferta de emprego

Ergomed Group seeks a Study Start Up and Regulatory Affairs Specialist to lead and coordinate activities ensuring site initiation readiness while ensuring regulatory compliance. The role serves as a key liaison between internal teams, clients, and external stakeholders across multiple jurisdictions.

The ideal candidate has a graduate degree in life sciences and experience in pharmaceutical/CRO environments with strong ICH-GCP knowledge.