Remote | FDA Regulatory Affairs Specialist — $120–$160/hour

We are sharing a specialised part-time consulting opportunity for experienced clinical regulatory professionals with substantial expertise in FDA review standards, information requests, clinical data packages, CMC, and regulatory evidence assessment. This role supports advanced clinical research workflows involving the validation of synthetic clinical data rooms and the development of realistic FDA information-request scenarios. Selected experts will assess whether clinical and regulatory materials meet FDA evidentiary and formatting expectations, identify deliberately embedded deficiencies, and develop authoritative reference responses grounded in real regulatory practice. Key Responsibilities FDA Regulatory Review Review clinical data rooms and supporting documents against FDA evidentiary standards Assess whether submitted information is complete, internally consistent, and appropriately supported Identify regulatory deficiencies, unsupported claims, and documentation gaps Evaluate whether materials would withstand substantive FDA review Detect deliberately embedded defects requiring experienced regulatory judgement Clinical Data & Evidence Assessment Review patient-level data and supporting clinical documentation Evaluate consistency between source data, analyses, narratives, and regulatory conclusions Assess whether evidence appropriately supports stated findings and claims Identify missing information, inconsistencies, and traceability concerns Apply regulatory judgement to complex or ambiguous evidence packages FDA Information Requests Develop realistic FDA-style requests for information Review and draft responses to regulatory information requests Evaluate whether responses directly and adequately address the underlying regulatory concern Identify incomplete, evasive, or insufficiently supported responses Produce reference responses reflecting strong regulatory practice CMC & Product Information Review Evaluate regulatory questions involving Chemistry, Manufacturing, and Controls (CMC) Assess whether manufacturing and product information adequately supports regulatory review Identify gaps in supporting evidence, documentation, or technical justification Review responses involving product quality and development information Apply appropriate regulatory standards to CMC-related information requests Investigator & Clinical Site Evidence Review questions involving investigator qualifications and study conduct Assess whether documentation appropriately supports investigator suitability and oversight Identify missing or inadequate qualification evidence Evaluate regulatory implications of deficiencies in investigator or site documentation Develop clear reference responses for related regulatory scenarios Biomarker & Endpoint Evidence Evaluate evidence supporting clinical biomarkers and study endpoints Assess whether proposed measures are sufficiently justified for their intended use Review supporting clinical and analytical evidence Identify overextended conclusions or evidence gaps Apply regulatory judgement to questions involving endpoint validity and interpretation Regulatory Task Development Design realistic regulatory-review tasks based on FDA workflows Develop clear prompts, expected outputs, and evaluation criteria Produce authoritative reference solutions for complex regulatory scenarios Define standards for accuracy, completeness, responsiveness, and evidentiary support Create tasks that distinguish genuine regulatory judgement from superficial rule application Quality & Validation Evaluate outputs for regulatory accuracy, internal consistency, and professional quality Verify that conclusions remain traceable to underlying evidence Distinguish substantive regulatory deficiencies from minor documentation issues Apply consistent standards across data rooms, information requests, and regulatory responses Provide precise written rationale for review findings Ideal Profile 5+ years of professional clinical regulatory or regulatory affairs experience , with 10–25 years preferred Direct experience reviewing or responding to FDA information requests Hands-on experience with regulatory questions involving: CMC Patient-level clinical data Investigator qualifications Biomarker or endpoint evidence Direct FDA review experience is strongly preferred Sponsor-side regulatory experience may also be relevant where it includes substantial FDA information-request work MD, PhD, PharmD, or equivalent advanced professional or academic qualification Strong understanding of FDA evidentiary standards and regulatory documentation expectations Excellent written communication and ability to develop precise regulatory responses Based in the United States, Canada, or France Candidates must not have a conflict of interest arising from current federal employment Engagement Details Part-time independent contractor engagement Fully remote Minimum availability of approximately 20–25 hours per week Availability of 30+ hours per week is preferred Flexible scheduling based on project requirements Compensation: $120–$160/hour Work may include clinical data-room validation, FDA information-request development, reference-output creation, and regulatory quality review Projects may be extended, shortened, or concluded based on project needs and performance Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, regulator, or other third party H1-B and STEM OPT support is unavailable for applicable engagements About the Platform This opportunity is available through 24-MAG LLC. 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