プロフィール詳細

プロジェクトを作成

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Shaheen Fathima A.に依頼

Canada

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

プロフィール概要

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.

専門分野

• ★ 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

サービス

• 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

職務経験

Regulatory affairs consultant

RegAscent Solutions

10月 2025 - 現在

AI Speech Trainer- Ambient Saxophone Project

Outlier

1月 2025 - 現在

AI Trainer & Regulatory/Biomedical Subject Matter Expert

Outlier

2月 2024 - 現在

Alumna

University of Madras

4月 2023 - 現在

Regulatory & QA Associate

Mahathi Biotech

7月 2022 - 8月 2024

Regulatory Affairs Intern

Mahathi Biotech

9月 2021 - 7月 2022

学歴

Bachelor of Science

University of Madras

8月 2020 - 4月 2023

認定資格

• Regulatory Affairs Certification

  Regulatory Affairs Professional Society (RAPS)

  1月 2026 - 現在

• FDA Office of Regulatory Affairs- Drug Regulation & Compliance

  FDA

  1月 2025 - 現在

• ICH-GCP Certification

  NIDA Clinical Trials Netwrok

  1月 2025 - 現在

• Good Laboratory Practice (GLP)- Nonclinical Development Standards

  FDA

  1月 2025 - 現在

• WHO/ICRC- Basic Emergency Care

  WHO

  1月 2025 - 現在

• Medical Billing and Coding

  MedCerts

  4月 2024 - 現在

• Advanced Cardiac Life Support

  NHCPS

  1月 2024 - 12月 2025