Senior Clinical Regulatory Affairs Evaluator (Remote)

ixolabs.ai; France; Sur place; EUR 66 000 - 102 000; Plein temps

Avantages offerts par ce poste

Remote work

Résumé du poste

ixolabs.ai is seeking a senior regulatory affairs expert to assess clinical regulatory documents and responses to health-authority questions. You will identify unsupported claims, regulatory risks, and explain deficiencies with reference to the regulatory framework.

The role prefers 5+ years in regulatory affairs with clinical submissions, knowledge of ICH/CTD/eCTD, and experience with multiple major agencies. RAC and AI-assisted tools are valued in a multi-region environment.

Qualifications

• 5+ years in regulatory affairs with responsibility for clinical submissions.
• Knowledge of ICH, CTD/eCTD and major agencies (FDA, EMA, MHRA, PMDA or Health Canada).
• Clinical/life-science degree; RAC adds value.
• Multi-region work and AI-supported regulatory tools are useful additions.

Responsabilités

• Assess clinical regulatory documents and responses to health-authority questions.
• Identify unsupported claims and regulatory risks in clinical/safety documents.
• Explain deficiencies with reference to the applicable regulatory framework.

Connaissances

Regulatory affairs

Agency liaison

Clinical documentation

Formation

Clinical or life-science degree

Outils

AI-assisted tools

Regulatory databases

Description du poste

ixolabs.ai is seeking a senior regulatory affairs expert to assess clinical regulatory documents and responses to health-authority questions. You will identify unsupported claims, regulatory risks, and explain deficiencies with reference to the regulatory framework.

The role prefers 5+ years in regulatory affairs with clinical submissions, knowledge of ICH/CTD/eCTD, and experience with multiple major agencies. RAC and AI-assisted tools are valued in a multi-region environment.