Job Description
Job DescriptionJob Title: Regulatory Affairs Specialist
Location: Remote
Job Type: ContractJob 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
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Review and evaluate clinical and regulatory documentation.
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Assess regulatory submissions and responses for accuracy and compliance.
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Ensure adherence to ICH guidelines and CTD/eCTD requirements.
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Identify regulatory risks, inconsistencies, and unsupported claims.
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Prepare structured, guideline-based written feedback.
Required Qualifications
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5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.
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Experience with clinical submissions, regulatory documentation, and health authority interactions.
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Strong knowledge of ICH guidelines and CTD/eCTD structure.
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Excellent analytical, critical thinking, and written communication skills.
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Degree in Life Sciences, Pharmacy, Medicine, or a related field.