Regulatory Affairs Expert Remote

We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents ensuring compliance with regulatory guidelines identifying inconsistencies and providing clear evidence-based feedback to improve AI-generated regulatory content.

• Review and evaluate clinical and regulatory documentation.

• Assess regulatory submissions and responses for accuracy and compliance.

• Ensure adherence to ICH guidelines and CTD/eCTD requirements.

• Identify regulatory risks inconsistencies and unsupported claims.

• Prepare structured guideline-based written feedback.

• 5 years of Regulatory Affairs experience in the pharmaceutical biotech or CRO industry.

• Experience with clinical submissions regulatory documentation and health authority interactions.

• Strong knowledge of ICH guidelines and CTD/eCTD structure.

• Excellent analytical critical thinking and written communication skills.

• Degree in Life Sciences Pharmacy Medicine or a related field.