Profile Details

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Hire Dr. Shifa J.

Canada

USD 30 /hr

Regulatory Affairs and Scientific Research professional

Profile Summary

Regulatory Affairs and Scientific Research professional with 6+ years of combined experience in biotech, academia, and government. Skilled in regulatory submissions, scientific writing, and preclinical R&D for Class IIa/IIb medical devices. Proficient in EU MDR, FDA, Health Canada, ICH-GCP (E6 R3), and ISO 13485 compliance. Experienced in drafting CERs, CEPs, SOPs, and managing literature reviews using PubMed, EndNote, and Veeva Vault. Strong background in mammalian cell culture, assay development, and GLP/GMP-aligned QC testing.

Subject Matter Expertise

• ☆ Cell Biology
• ☆ Cell Culture
• ☆ Drug Development
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ Clinical Trials
• ☆ Regulatory Affairs

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Copywriting, Creative Writing, General Proofreading & Editing

Work Experience

Regulatory Operations Officer

Health Canada

May 2024 - August 2024

Regulatory Operations Officer

Health Canada

May 2024 - August 2024

Medical writer- Baxter

Actalent Services

August 2022 - December 2022

Medical Writer

Actalent Services

August 2022 - December 2022

Scientist

Mediphage Bioceuticals

November 2018 - March 2022

Scientist

Mediphage Bioceuticals

November 2018 - March 2022

Research Fellow

Postgraduate Institute of Medical Education and Research

April 2012 - September 2018

Education

Graduate certificate

Seneca Polytechnic

January 2024 - December 2024

Regulatory Affairs and Quality Operations

Seneca Polytechnic

January 2024 - December 2024

PhD

PGIMER, Chandigarh, India

June 2014 - September 2018

Doctor of Philosophy (Department of Cytology and GynecPathology)

Postgraduate Institute of Medical Education and Research

April 2014 - September 2018

Certifications

• RAQC

  Seneca Polytechnic

  December 2024 - Present

Publications

JOURNAL ARTICLE

Shifa Javed, Swati Sood, Bhavana Rai, Shalmoli Bhattacharyya, Rashmi Bagga, Radhika Srinivasan (2021). ALDH1 & CD133 in invasive cervical carcinoma & their association with the outcome of chemoradiation therapy . Indian Journal of Medical Research.

Shifa Javed, Shalmoli Bhattacharyya, Rashmi Bagga, Radhika Srinivasan (2020). Insulin growth factor-1 pathway in cervical carcinoma cancer stem cells . Molecular and Cellular Biochemistry.

Shifa Javed, Anuka Sharma, Renaissa De, Radhika Srinivasan, Arnab Pal, Shalmoli Bhattacharyya (2019). Sonic hedgehog pathway activation regulates cervical cancer stem cell characteristics during epithelial to mesenchymal transition . Journal of Cellular Physiology.

Shifa Javed, Bal Krishan Sharma, Swati Sood, Sanjeev Sharma, Rashmi Bagga, Shalmoli Bhattacharyya, Charan Singh Rayat, Lakhbir Dhaliwal, Radhika Srinivasan (2018). Significance of CD133 positive cells in four novel HPV-16 positive cervical cancer-derived cell lines and biopsies of invasive cervical cancer . BMC Cancer.

Shifa Javed, Bal Krishan Sharma, Sanjeev Kumar Sharma, Swati Sood, Rashmi Bagga, Shalmoli Bhattacharyya, Radhika Srinivasan (2016). Abstract 3347: Establishment of four novel HPV-16 positive cell lines of invasive cervical carcinoma of Indian origin and characterization of CD133 positive cancer stem cells . Cancer Research.

Shifa Javed, Nargis Khan, Aurobind Vidyarthi, Javed N. Agrewala (2016). Innate Immunity Holding the Flanks until Reinforced by Adaptive Immunity against Mycobacterium tuberculosis Infection . Frontiers in Microbiology.