Remote | Regulatory Affairs Specialist — $50–$80/hour

We are sharing a specialised consulting opportunity for experienced Regulatory Affairs Specialists with strong expertise in clinical regulatory submissions, ICH guidelines, CTD/eCTD structure, health authority interactions, clinical documentation review, and regulatory risk assessment to contribute to an advanced AI training and regulatory-documentation evaluation project.

Selected professionals will review complex regulatory materials, assess sponsor responses to health authority requests, identify unsupported or conflicting claims, and provide structured written feedback grounded in applicable regulatory standards. The work requires strong regulatory judgement, document-level consistency review, and the ability to distinguish substantive adequacy from polished but insufficient responses. No prior experience in AI is required.

Key Responsibilities

Regulatory Response Evaluation

• Author and review evaluation tasks based on realistic health authority requests and sponsor-response workflows
• Assess whether drafted responses meet applicable regulatory expectations
• Evaluate whether commitments are appropriately scoped and supported
• Identify responses that are incomplete, misleading, or insufficiently substantiated
• Provide clear reasoning explaining regulatory deficiencies

Clinical Documentation Review

• Review clinical and safety documentation for regulatory adequacy
• Assess whether conclusions are supported by underlying evidence
• Identify unsupported statements, omissions, or inconsistencies
• Evaluate whether documentation could withstand regulatory scrutiny
• Flag potential reviewer concerns and regulatory risks

ICH & CTD/eCTD Assessment

• Apply working knowledge of ICH guidelines to regulatory review tasks
• Evaluate documentation within CTD and eCTD structures
• Assess whether information is organised appropriately across submission sections
• Identify inconsistencies across modules or supporting documents
• Apply regulatory expectations consistently across evaluation tasks

Health Authority Interaction Analysis

• Review scenarios involving requests from major regulatory authorities
• Evaluate sponsor responses for clarity, completeness, and defensibility
• Assess whether responses appropriately address agency concerns
• Identify commitments or statements that may create unintended regulatory exposure
• Apply practical knowledge of agency expectations to realistic scenarios

Cross-Document Consistency Review

• Assess consistency across comprehensive document sets
• Identify conflicting statements between clinical, safety, and regulatory materials
• Detect unsupported claims or conclusions that do not align with source evidence
• Evaluate whether key regulatory messages remain consistent across documents
• Provide structured commentary on discrepancies and required corrections

Regulatory Risk Identification

• Identify regulatory risks within clinical and safety documentation
• Distinguish material deficiencies from stylistic or superficial issues
• Anticipate potential reviewer questions or objections
• Evaluate the likely significance of documentation gaps
• Prioritise issues based on regulatory relevance and potential impact

Structured Regulatory Feedback

• Provide clear, well-reasoned written feedback
• Ground conclusions in applicable regulatory guidance rather than subjective impressions
• Explain complex regulatory concepts precisely and concisely
• Develop defensible rationales for evaluation decisions
• Maintain consistent standards across repeated review tasks

Remote Collaboration

• Collaborate asynchronously with project leads and other subject-matter experts
• Communicate complex regulatory issues clearly in written and verbal formats
• Clarify ambiguous project requirements where necessary
• Contribute to calibration and quality-improvement discussions
• Support consistent regulatory interpretation across distributed project teams

Ideal Profile

• 5+ years of direct regulatory affairs experience
• Experience working at a sponsor, CRO, consultancy, or comparable regulatory environment
• Direct responsibility for clinical regulatory submissions
• Documented experience drafting or leading responses to health authority information requests
• Strong working knowledge of the ICH framework
• Experience with CTD and eCTD submission structures
• Practical knowledge of at least one major regulatory authority, such as FDA, EMA, MHRA, PMDA, or Health Canada
• Strong ability to critically review clinical and safety documents
• Experience identifying unsupported claims, regulatory risks, and reviewer concerns
• Exceptional written communication skills
• Strong critical-thinking and analytical judgement
• Excellent attention to detail
• Degree in life sciences, pharmacy, medicine, or a related discipline
• RAC certification is advantageous
• Experience working across multiple regulatory regions or agencies is valuable
• Prior health authority reviewer or assessor experience is advantageous
• Familiarity with AI-assisted regulatory tools is beneficial but not required
• No prior AI-training or model-evaluation experience is required

Engagement Details

• Independent contractor engagement
• Fully remote
• Compensation: $50–$80/hour
• Work will involve regulatory response evaluation, clinical-document review, ICH guideline application, CTD/eCTD assessment, health authority interaction analysis, regulatory-risk identification, and structured written feedback
• Strong regulatory-affairs judgement and clinical-submission experience are central to this engagement
• Assignments may involve health authority requests, sponsor-response threads, clinical documentation, safety materials, regulatory submissions, and cross-document consistency reviews
• Collaboration will primarily occur asynchronously with project leads and other domain experts
• Project scope, workload, regulatory topics, and evaluation standards may evolve depending on project requirements
• Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, CRO, consultancy, healthcare organisation, regulatory body, or other third party

About the Platform

This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.

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