Senior RASSU Regulatory Lead

Cti; Almada; On-site; EUR 40,000 - 65,000; Full time

Job summary

CTI is seeking an experienced Regulatory Affairs professional to support Study Start-Up activities in our European operations. You will advise project teams on regulatory requirements for clinical studies and oversee submissions to IRB/IEC and other authorities.

You will review study documents for country-specific needs, prepare regulatory packages, adapt informed consent forms, and ensure quality and completeness of materials, while collaborating with sites, sponsors, and PMs.

Qualifications

• Associate's or bachelor's degree in allied health field or equivalent experience.
• 8–10 years regulatory experience in pharma/CRO.
• Fluent in English (spoken and written).

Responsibilities

• Assist project teams on regulatory requirements for clinical studies.
• Perform compliance assessments per country requirements.
• Notify PMs of regulatory findings.
• Review study documents for country and site requirements.
• Oversee IRB/IEC submissions on behalf of sponsors/sites.
• Process study documentation quality and completeness.
• QC/QA of regulatory documents and reports.
• Prepare regulatory submissions and adapt ICFs as needed.
• Interact with sponsors, sites, CPCs, CRAs, and PMs.
• Train and mentor junior regulatory staff.

Skills

Regulatory knowledge

Documentation review

Quality control

Project coordination

Fluent English

Education

Bachelor's degree in health field

Job description

CTI is seeking an experienced Regulatory Affairs professional to support Study Start-Up activities in our European operations. You will advise project teams on regulatory requirements for clinical studies and oversee submissions to IRB/IEC and other authorities.

You will review study documents for country-specific needs, prepare regulatory packages, adapt informed consent forms, and ensure quality and completeness of materials, while collaborating with sites, sponsors, and PMs.