[Hiring] Regulatory Affairs Specialist @24-MAG

Role Description

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 feedback grounded in applicable regulatory standards. No prior experience in AI is required.

Key Responsibilities

• Regulatory Submission & Health Authority Review
  • Evaluate sponsor responses to health authority requests for completeness, clarity, and regulatory adequacy
  • Assess whether commitments, claims, and proposed actions are appropriately scoped and supported
  • Review clinical and safety documentation for consistency with regulatory expectations
  • Identify incomplete, misleading, unsupported, or insufficiently substantiated responses
  • Apply practical knowledge of FDA, EMA, MHRA, PMDA, Health Canada, or comparable authority expectations
• ICH, CTD/eCTD & Cross-Document Assessment
  • Apply relevant ICH guidelines across regulatory review tasks
  • Evaluate documentation within CTD and eCTD structures
  • Assess consistency across clinical, safety, and regulatory materials
  • Identify conflicting statements, unsupported conclusions, or misalignment with source evidence
  • Review whether submission content is organised and presented appropriately for regulatory use
• Regulatory Risk & Quality Evaluation
  • Identify material regulatory risks, documentation gaps, and potential reviewer concerns
  • Distinguish substantive deficiencies from stylistic or superficial issues
  • Evaluate the significance and potential impact of identified issues
  • Provide clear, defensible written rationales grounded in regulatory guidance
  • Support reviewer calibration and consistent regulatory interpretation across project tasks

Qualifications

• 5+ years of direct regulatory affairs experience
• Experience at a sponsor, CRO, consultancy, or comparable regulatory environment
• Direct responsibility for clinical regulatory submissions
• Experience drafting or leading responses to health authority information requests
• Strong working knowledge of ICH guidelines and CTD/eCTD structures
• Practical experience with at least one major regulatory authority such as FDA, EMA, MHRA, PMDA, or Health Canada
• Strong ability to critically review clinical and safety documentation
• Experience identifying unsupported claims, regulatory risks, and reviewer concerns
• Exceptional written communication, analytical judgement, and attention to detail
• Degree in life sciences, pharmacy, medicine, or a related discipline
• RAC certification, multi-region regulatory experience, or prior health authority reviewer 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
• 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