Senior Regulatory Affairs Study Start-Up Lead

Ctifacts; Portugal; Teletrabalho; EUR 70 000 - 100 000; Tempo integral

Resumo da oferta

CTI is seeking a Regulatory Affairs Study Start-Up professional to support the RASSU department across multiple sites. You will advise project teams on regulatory requirements for clinical studies, perform compliance assessments, review country-specific documents, and oversee regulatory submissions with sponsors and sites.

Responsibilities include coordinating IRB/IEC submissions, compiling regulatory packages, and ensuring timely responses to deficiency letters.

Qualificações

• Associate’s or bachelor’s degree in allied health field.
• 8–10 years of pharmaceutical or CRO regulatory experience.
• Fluent in spoken and written English.

Responsabilidades

• Assist project teams on regulatory requirements for clinical studies.
• Perform compliance assessments and notify Project Managers of findings.
• Review and adapt study documents to country/site requirements.
• Oversee regulatory submissions (IRB/IEC/other bodies) as needed.
• Interact with site personnel to correct incomplete documentation.

Conhecimentos

Regulatory experience

English fluency

Formação académica

Associate or Bachelor's degree in allied health

Descrição da oferta de emprego

CTI is seeking a Regulatory Affairs Study Start-Up professional to support the RASSU department across multiple sites. You will advise project teams on regulatory requirements for clinical studies, perform compliance assessments, review country-specific documents, and oversee regulatory submissions with sponsors and sites.

Responsibilities include coordinating IRB/IEC submissions, compiling regulatory packages, and ensuring timely responses to deficiency letters.