EU Regulatory Submissions Specialist II | CTIS Expert

CTI Clinical Trial and Consulting Services; Lisboa; Hybride; EUR 45 000 - 65 000; Plein temps

Résumé du poste

CTI Clinical Trial and Consulting Services seeks an experienced Regulatory Affairs professional to prepare, review, and manage regulatory submissions in CTIS and other national systems. You will support EC/CA submissions, ICF updates, and maintain compliant regulatory documentation across sites and sponsors.

The role involves interaction with country teams, sponsor communications, and QA of regulatory documents, with a focus on timely and accurate submissions and responses to regulators.

Qualifications

• Bachelor's degree in allied health or equivalent experience.
• Minimum 3 years regulatory experience in CRO/pharma/site.
• Experience with EC/CA submissions and CTIS is preferred.

Responsabilités

• Prepare, review, and manage regulatory submissions under CTR using CTIS.
• Handle regulatory submissions for medical devices, GMOs, and local country requirements.
• Prepare and QC Clinical Trial Application forms where applicable.
• Respond to Deficiency Letters from EC/CA and other regulators.
• Compile regulatory documentation and ensure accuracy for drug release.

Connaissances

Regulatory submissions

Documentation management

Cross-functional communication

Quality assurance

Formation

Bachelor's degree in allied health

Outils

CTIS

eTMF system

Description du poste

CTI Clinical Trial and Consulting Services seeks an experienced Regulatory Affairs professional to prepare, review, and manage regulatory submissions in CTIS and other national systems. You will support EC/CA submissions, ICF updates, and maintain compliant regulatory documentation across sites and sponsors.

The role involves interaction with country teams, sponsor communications, and QA of regulatory documents, with a focus on timely and accurate submissions and responses to regulators.