Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 35 /hr

★★★★★

☆☆☆☆☆

Hire Shaheen Fathima A.

Canada

USD 35 /hr

Regulatory Affairs & Clinical Research Consultant | Drug Development, Compliance & Scientific Writing

Profile Summary

I am a Regulatory Affairs and Clinical Research professional with expertise spanning drug development, compliance strategy, and scientific documentation. Currently preparing for the RAC (Global) certification from RAPS, I bring a strong foundation in international regulations (FDA, EMA, Health Canada, GCC authorities) and hands-on knowledge of global harmonization frameworks (ICH, WHO). My core skills include: Regulatory Strategy & Documentation: IND/IB/CSR development, clinical trial protocols, investigator brochures, and submission-ready dossiers. Clinical Research Support: Site startup guidance, safety pharmacology assessments, risk–benefit analysis, and GCP compliance. Medical & Scientific Writing: Systematic literature reviews, real-world evidence synthesis, publication-ready manuscripts, and regulatory-grade summaries. Global Insight: Familiar with regulatory landscapes across North America, Europe, Middle East (UAE, Qatar, Saudi Arabia, Oman), and India. I am particularly skilled at translating complex scientific data into clear, compliant, and actionable documents that support successful submissions and accelerate development timelines. My career vision is to partner with biotech innovators, pharmaceutical sponsors, CROs, and academic researchers in bringing safe, effective therapies to market. Whether you need end-to-end regulatory support or focused assistance with medical writing and evidence synthesis, I provide reliable, detail-oriented consulting with a global perspective.

Subject Matter Expertise

• ★ Pharmaceutical Regulatory Affairs
• ★ Regulatory Affairs
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Clinical Trials
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ 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

Research Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Product Evaluation, Product Validation, Product Compliance

Work Experience

AI Model Trainer & Subject Matter Expert (Biology)

Outlier AI

July 2024 - Present

Academic Science Tutor

Tootor.ca

July 2024 - Present

Alumna

University of Madras

April 2023 - Present

Quality Assurance and Regulatory Affairs

Mahathi Biotech

September 2021 - August 2024

Research Intern

Biodeavour Research Lab

August 2022 - September 2022

Medical Content Writer

NearbyMe2.com

November 2021 - December 2021

Education

Bachelor of Science

University of Madras

August 2020 - April 2023

Certifications

• 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