FDA Regulatory Affairs Specialist

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, Canada, +1 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇫🇷 France – Remote

🗽 New York – Remote

🗽 New York – Remote

💵 $120 - $160 / hour

⏱ Part Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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24-MAG

WebsiteLinkedInAll Job Openings

2 - 10 employees

🤝 B2B

💼 Consulting

B2B • Consulting

24-MAG is a commercial strategy and execution firm that helps B2B organizations design and implement systems, workflows, and operating rhythms for sales, client management, and cross-functional projects. They focus on transforming scattered processes into aligned, measurable, and scalable commercial functions—covering pipeline structure, account management frameworks, and operational discipline for teams seeking efficient, intentional growth.

📋 Description

• Review clinical data rooms and supporting documents against FDA evidentiary standards • Assess completeness, internal consistency, evidentiary support, formatting, and regulatory readiness of clinical and regulatory materials • Identify regulatory deficiencies, unsupported claims, documentation gaps, embedded defects, missing information, inconsistencies, and traceability concerns • Review patient-level data and supporting clinical documentation • Evaluate consistency between source data, analyses, narratives, and regulatory conclusions • Develop realistic FDA-style requests for information • Review and draft responses to regulatory information requests • Evaluate whether responses directly and adequately address regulatory concerns • Produce authoritative reference responses grounded in strong regulatory practice • Evaluate CMC, manufacturing, product quality, and product development information • Review investigator qualifications, study conduct, investigator suitability, oversight, and clinical-site documentation • Evaluate evidence supporting clinical biomarkers and study endpoints • Design regulatory-review tasks based on FDA workflows, including prompts, expected outputs, evaluation criteria, and reference solutions • Evaluate outputs for regulatory accuracy, internal consistency, traceability, and professional quality • Apply consistent standards and provide precise written rationale for review findings

🎯 Requirements

• 5+ years of professional clinical regulatory or regulatory affairs experience; 10–25 years preferred • Direct experience reviewing or responding to FDA information requests • Hands-on experience with CMC • Hands-on experience with patient-level clinical data • Hands-on experience with investigator qualifications • Hands-on experience with biomarker or endpoint evidence • Direct FDA review experience strongly preferred • Sponsor-side regulatory experience may 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 • Must not have a conflict of interest arising from current federal employment • Minimum availability of approximately 20–25 hours per week • Work must be completed without using confidential or proprietary information belonging to any employer, sponsor, client, institution, regulator, or other third party

🏖️ Benefits

• Part-time independent contractor engagement • Fully remote • Flexible scheduling based on project requirements • Availability of 30+ hours per week preferred • Projects may be extended, shortened, or concluded based on project needs and performance • H1-B and STEM OPT support is unavailable for applicable engagements