Regulatory Submissions Expert – EU CTIS & Clinical Trials

CTI; Lisboa; On-site; EUR 40,000 - 65,000; Full time

Job summary

CTI Clinical Trial and Consulting Services seeks a regulatory professional to prepare and manage submissions under CTR using CTIS, and to handle EC/CA processes across countries. You will ensure compliant documentation and timely responses to deficiency letters while coordinating with sponsors and sites.

The role covers regulatory document review, dossier preparation, ICF alignment, and study start-up checks, with a focus on EU standards.

Qualifications

• Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• Minimum of 3 years of regulatory experience in a CRO, pharmaceutical industry, or site environment.

Responsibilities

• Prepare regulatory submissions under CTR using CTIS.
• Handle regulatory submissions for medical devices, GMOs, and local country requirements.
• Prepare and QC Clinical Trial Application forms (via CTIS or other systems).
• Perform EC/CA submissions on behalf of sponsors/sites.
• Respond to Deficiency Letters from EC/CA and other regulatory bodies.
• Compile and assess regulatory document packages for drug release.

Skills

Regulatory submissions

EC/CA coordination

CTIS knowledge

Documentation QC

Education

Bachelor’s degree in allied health fields

Job description

CTI Clinical Trial and Consulting Services seeks a regulatory professional to prepare and manage submissions under CTR using CTIS, and to handle EC/CA processes across countries. You will ensure compliant documentation and timely responses to deficiency letters while coordinating with sponsors and sites.

The role covers regulatory document review, dossier preparation, ICF alignment, and study start-up checks, with a focus on EU standards.