Regulatory Affairs Specialist - Remote

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.