Clinical Regulatory Expert

Position: Clinical Regulatory Expert

Type: Freelance Hourly Contract

Compensation: $130–$170/hour

Location: Remote

About the Opportunity

This opportunity is for experienced Clinical Regulatory Affairs professionals interested in contributing to advanced AI research and evaluation projects involving FDA regulatory review processes, clinical data packages, and regulatory information requests.

The role focuses on validating clinical and regulatory documentation, designing realistic FDA review scenarios, and creating evaluation frameworks that measure how effectively AI systems perform complex regulatory reasoning tasks.

You'll apply your expertise in FDA submissions, clinical development, regulatory strategy, data review, and information request management to help improve next-generation AI systems used in life sciences and healthcare.

Key Responsibilities

- Review and validate clinical data rooms and regulatory documentation against FDA evidentiary standards and submission requirements.
- Evaluate clinical trial documents, supporting evidence, and regulatory packages for completeness, accuracy, and regulatory compliance.
- Design realistic FDA Information Request (RFI) scenarios and regulatory review workflows.
- Author regulatory prompts, reference answers, golden outputs, and evaluation rubrics for AI model assessment.
- Review and assess AI-generated regulatory responses for scientific accuracy, regulatory soundness, and submission readiness.
- Create benchmark tasks involving CMC reviews, patient-level data requests, investigator qualifications, biomarker evidence,



and clinical endpoints.
- Provide expert feedback to improve AI reasoning in regulatory affairs and clinical development workflows.
- Contribute to the development of high-quality regulatory evaluation frameworks and datasets.

Required Qualifications

- 5+ years of experience in clinical regulatory affairs, regulatory review, or FDA-related regulatory operations ( 10–25 years preferred ).
- Advanced degree such as MD, PhD, PharmD, or equivalent .
- Direct experience reviewing or responding to FDA Information Requests across regulatory, clinical, or scientific functions.
- Solid knowledge of FDA evidentiary standards, submission requirements, and regulatory review processes.
- Experience with CMC reviews, patient-level data requests, investigator qualifications, biomarkers, and endpoint evidence.
- Ability to commit 20–25+ hours per week .
- Excellent written communication and regulatory documentation skills.

Preferred Qualifications

- Direct FDA reviewer experience.
- Experience authoring regulatory guidance, review documentation, or evaluation frameworks.
- Deep understanding of clinical development, regulatory strategy, and submission lifecycle management.
- Familiarity with AI-assisted review workflows and evaluation methodologies.
- Experience designing training materials, rubrics, or regulatory assessment frameworks.

Compensation

- Competitive compensation of $130–$170/hour
- Weekly payments
- Independent contractor engagement

Application Process

1. Easy Apply on LinkedIn
2. Check Email for Next Steps
3. Participate in Resume Evaluation & Interview Stage

📌 Clinical Regulatory Specialist (Remote | $130–$170/hr) (Canada)
🏢 Synthires
📍 Canada