Clinical Regulatory Affairs Evaluation

ixolabs.ai; France; Hybride; 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

Assess clinical regulatory documents and responses to health-authority questions. Determine whether claims and commitments are supported, find inconsistencies across the record and explain substantive deficiencies with reference to the applicable regulatory framework.

Professional background

The preferred profile has five or more years in regulatory affairs with responsibility for clinical submissions and responses to health-authority questions. Know ICH, CTD/eCTD and the practical requirements of at least one major agency such as FDA, EMA, MHRA, PMDA or Health Canada. You should find unsupported claims and regulatory risks in clinical/safety documents and explain them defensibly. A relevant clinical/life-science degree is preferred; RAC adds value. Multi-region work, agency reviewer experience and AI-supported regulatory tools are useful additions.

Working arrangements

This is remote, paid IXO expert work. Agree the specific task brief, permitted materials, outputs and working schedule with IXO before starting. Any commitment or duration described in a practice profile is an indicative planning requirement for that route, subject to that agreement.

Pay

• $55
• $85/hr USD

The applicable rate is agreed for the work and professional track before you begin.

Use only materials you are authorized to share, and keep private or restricted information out of your submissions.