Regulatory Affairs Expert - Remote
Job Title: Regulatory Affairs Specialist
Location: Remote
Job Type: Contract
reputed company
We are seeking an reputed company Regulatory Affairs Specialist to support AI-driven reputed company reputed company by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing reputed company, 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 reputed company, reputed company-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 reputed company field.
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