Clinical Regulatory Affairs Evaluation

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.