プロフィール詳細

プロジェクトを作成

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Dr. Shifa J.に依頼

Canada

Regulatory Affairs and Scientific Research professional

プロフィール概要

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.

専門分野

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

サービス

• Writing

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

職務経験

Regulatory Operations Officer

Health Canada

5月 2024 - 8月 2024

Regulatory Operations Officer

Health Canada

5月 2024 - 8月 2024

Medical writer- Baxter

Actalent Services

8月 2022 - 12月 2022

Medical Writer

Actalent Services

8月 2022 - 12月 2022

Scientist

Mediphage Bioceuticals

11月 2018 - 3月 2022

Scientist

Mediphage Bioceuticals

11月 2018 - 3月 2022

Research Fellow

Postgraduate Institute of Medical Education and Research

4月 2012 - 9月 2018

学歴

Graduate certificate

Seneca Polytechnic

1月 2024 - 12月 2024

Regulatory Affairs and Quality Operations

Seneca Polytechnic

1月 2024 - 12月 2024

PhD

PGIMER, Chandigarh, India

6月 2014 - 9月 2018

Doctor of Philosophy (Department of Cytology and GynecPathology)

Postgraduate Institute of Medical Education and Research

4月 2014 - 9月 2018

認定資格

• RAQC

  Seneca Polytechnic

  12月 2024 - 現在

出版物

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.