Regulatory Affairs Expert - Remote

Summary

Job Description Job Description Job Title: Regulatory Affairs Specialist
Location: Remote
Job Type: Contract Job Description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Job Description

Job Description Job Description Job Title: Regulatory Affairs Specialist
Location: Remote
Job Type: Contract Job Description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.