Strategic Study Start-Up & Regulatory Affairs Lead

Ergomed; Lisboa; Presencial; EUR 52 000 - 76 000; Tempo integral

Resumo da oferta

Ergomed is a specialist CRO focusing on rare disease and oncology trials, delivering complex studies with rigorous operational accountability. The Specialist, Study Start Up and Regulatory Affairs coordinates all SSU activities, ensuring regulatory compliance and acting as a key liaison between internal teams, clients, and external stakeholders.

The role involves drafting and negotiating site agreements, preparing regulatory submissions, and guiding translations to meet country-specific

Qualificações

• Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
• 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 SSU 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 SSU documentation (submissions, essential documents, translations) for completeness and compliance with ICH-GCP and country-specific requirements.
• Draft, negotiate, finalize, and execute site, ancillary agreements and amendments at country or regional level.
• Review labels, patient information sheets, diary cards, insurance, etc. for compliance with regulatory requirements.
• Provide regulatory/SSU strategic input; develop regulatory strategy and SSU Plan, SOPs and core documents.
• Identify risks and suggest corrective actions to keep deliverables on track.

Conhecimentos

Regulatory affairs

ICH GCP knowledge

Multi-country SSU

Formação académica

Graduate degree

Descrição da oferta de emprego

Ergomed is a specialist CRO focusing on rare disease and oncology trials, delivering complex studies with rigorous operational accountability. The Specialist, Study Start Up and Regulatory Affairs coordinates all SSU activities, ensuring regulatory compliance and acting as a key liaison between internal teams, clients, and external stakeholders.

The role involves drafting and negotiating site agreements, preparing regulatory submissions, and guiding translations to meet country-specific