Regulatory Affairs Expert - Remote
Job Title: Regulatory Affairs Specialist Job Type: Contractor Location: Remote Job Overview We are seeking experienced Regulatory Affairs Specialists to contribute their regulatory expertise to an innovative project focused on improving AI-driven regulatory documentation systems. In this role, you will help enhance next-generation AI models by reviewing, evaluating, and refining regulatory content, submissions, and clinical documentation. No prior AI experience is required—your regulatory knowledge, analytical skills, and industry expertise are what matter most.
Key Responsibilities
- Author and review evaluation tasks based on real-world regulatory requests, submissions, and sponsor response scenarios.
- Review clinical documentation to assess regulatory compliance, accuracy, and alignment with health authority expectations.
- Evaluate regulatory responses to determine completeness, justification, and readiness for submission.
- Identify unsupported claims, inconsistencies, and potential regulatory risks across document sets.
- Provide structured, guideline-based written feedback and recommendations.
- Assess documents according to applicable regulatory standards and industry best practices.
- Collaborate remotely with project teams to communicate complex regulatory concepts clearly.
Required Skills
- Regulatory Affairs
- Clinical Documentation Review
- ICH Guidelines
- CTD/eCTD Structure
- Regulatory Submissions
- Health Authority Interactions
- Written Communication
- Critical Thinking
- Attention to Detail
- Remote Collaboration
Preferred Qualifications
- 5+ years of direct regulatory affairs experience within a sponsor, CRO, or consultancy environment.
- Experience managing clinical submissions and responding to health authority information requests.
- Strong knowledge of the ICH framework, CTD/eCTD structure, and regulatory expectations of agencies such as FDA, EMA, MHRA, PMDA, or Health Canada.
- Ability to critically review clinical and safety documents to identify regulatory risks and reviewer concerns.
- Excellent written communication skills with the ability to present regulatory reasoning clearly and accurately.
- Degree in life sciences, pharmacy, medicine, or related field; RAC certification is a plus.
- Experience working across multiple regions, prior health authority reviewer experience, or familiarity with AI-assisted regulatory tools is highly valued.
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