Regulatory Affairs Expert Remote
Job Location:
Austin, TX - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Location: Remote
Job Type: Contract
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.
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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.
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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.
