Profile Details

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USD 75 /hr

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Hire Shaheen Fathima A.

Canada

USD 75 /hr

RAC-Drugs Certified Regulatory Affairs Consultant | FDA · EMA · Health Canada | IND, NDA, eCTD & Medical Writing

Profile Summary

Regulatory documentation either moves a program forward or it doesn't. I make sure it does. I'm a RAC-Drugs certified Regulatory Affairs consultant (2026–2029) with 4+ years of hands-on experience supporting pharma, biotech, and medtech teams across FDA, Health Canada, EMA, CDSCO, GCC, and ICH frameworks. I deliver submission-ready documentation — not drafts that need rework. Core expertise: — IND/CTA and NDA/ANDA module drafting (Modules 2–5) — EU Pediatric Investigation Plans (PIPs) and US Pediatric written requests — eCTD structure, publishing, and sequence preparation — Clinical writing: Protocols, IBs, CSRs, safety summaries — Labeling: USPI, SmPC, CCDS review and compliance — MDR/IVDR: CERs, PERs, and technical file support — Regulatory gap analysis and audit readiness — SOPs, QA systems, CAPA documentation I work with early-stage and growing life sciences teams who need senior-level regulatory execution without large firm overhead. Every deliverable is structured, defensible, and submission-ready. Available for project-based engagements globally. Response within hours.

Subject Matter Expertise

• ★ Regulatory Affairs
• ★ NDA/BLA Applications
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ CMC Documentation
• ☆ Nonclinical Study Documentation
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Research Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Product Evaluation, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance

Work Experience

Regulatory affairs consultant

RegAscent Solutions

October 2025 - Present

AI Speech Trainer- Ambient Saxophone Project

Outlier

January 2025 - Present

AI Trainer & Regulatory/Biomedical Subject Matter Expert

Outlier

February 2024 - Present

Alumna

University of Madras

April 2023 - Present

Regulatory & QA Associate

Mahathi Biotech

July 2022 - August 2024

Regulatory Affairs Intern

Mahathi Biotech

September 2021 - July 2022

Education

Bachelor of Science

University of Madras

August 2020 - April 2023

Certifications

• Regulatory Affairs Certification

  Regulatory Affairs Professional Society (RAPS)

  January 2026 - Present

• FDA Office of Regulatory Affairs- Drug Regulation & Compliance

  FDA

  January 2025 - Present

• ICH-GCP Certification

  NIDA Clinical Trials Netwrok

  January 2025 - Present

• Good Laboratory Practice (GLP)- Nonclinical Development Standards

  FDA

  January 2025 - Present

• WHO/ICRC- Basic Emergency Care

  WHO

  January 2025 - Present

• Medical Billing and Coding

  MedCerts

  April 2024 - Present

• Advanced Cardiac Life Support

  NHCPS

  January 2024 - December 2025