Senior Regulatory Start-Up Specialist — Global Trials

CTI Clinical Trial and Consulting Services; España; Híbrido; EUR 60.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work opportunities

Mentoring program

Leadership development courses

Descripción de la vacante

CTI Clinical Trial and Consulting Services is seeking an experienced Regulatory Affairs professional to support Study Start-Up (RASSU) activities across multiple countries. You will advise project teams on regulatory requirements and oversee submissions to IRBs/ECs, ensuring quality and compliance across sites.

Responsibilities include adapting study documents, coordinating with site personnel, and maintaining regulatory packages per sponsor SOPs.

Formación

• Associate’s or bachelor’s degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience.
• A minimum of 8 - 10 years relevant 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 document findings for country requirements.
• Review and adapt study documents per country/site requirements.
• Prepare regulatory submissions (IRB/IEC and others) on behalf of sponsors/sites as agreed.

Conocimientos

Fluent English

Educación

Associate’s or bachelor’s degree in allied health

Descripción del empleo

CTI Clinical Trial and Consulting Services is seeking an experienced Regulatory Affairs professional to support Study Start-Up (RASSU) activities across multiple countries. You will advise project teams on regulatory requirements and oversee submissions to IRBs/ECs, ensuring quality and compliance across sites.

Responsibilities include adapting study documents, coordinating with site personnel, and maintaining regulatory packages per sponsor SOPs.