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.
Remote Skills: Analysis Skills, Artificial Intelligence (AI), Biology, Clinical Practices/Protocols, Clinical Study Publications, Communication Skills, Documentation, Healthcare, ICH Regulations, Maintain Compliance, Medicine, Pharmacy, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Analysis, Writing Skills YO AI Labs Apply To This Job