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

24-Mag•New York, NY

3d•Remote

About The Position

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.

Requirements

5+ years of professional clinical regulatory or regulatory affairs experience
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
Based in the United States, Canada, or France
Candidates must not have a conflict of interest arising from current federal employment

Nice To Haves

10–25 years preferred experience
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
Availability of 30+ hours per week is preferred

Responsibilities

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
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
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
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
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
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
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
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