プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Akbar Z.に依頼

Estonia

Regulatory Affairs Specialist (EMA/EU) | Pharmacovigilance | Scientific & Medical Writing

プロフィール概要

I am a Regulatory Affairs Specialist and dQPPV with expertise in EMA and EU submissions, pharmacovigilance, and compliance documentation. I currently work in the European pharmaceutical industry, managing variations, renewals, CTD/eCTD dossiers, SOPs, SPCs, PILs, and stability reports for national and MRP medicinal products. My background includes a PhD in Neurosciences and postdoctoral research, giving me a strong scientific foundation to support regulatory strategy and medical writing. I have also authored peer-reviewed publications and health-related articles, which allows me to produce documentation that is both technically precise and clearly communicated. Areas of expertise: - EMA regulatory submissions (variations, renewals, CTD/eCTD) - EU MDR compliance for pharmaceuticals and medical devices - Pharmacovigilance (dQPPV activities, EMA safety reports) - SOP development, validation & stability reporting - Labeling & artwork review (SPC, PIL, mock-ups) - Literature reviews and medical writing I provide accurate, compliant, and timely documentation to help companies achieve faster approvals and maintain regulatory compliance.

専門分野

• ☆ Neuroscience
• ☆ Regulatory Affairs
• ☆ Medical Writing
• ☆ SEO Medical Writing

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing

Research Systematic Literature Review

Consulting Healthcare Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Validation, Product Compliance , Packaging Design

職務経験

Regulatory Affairs Specialist and dQPPV

Interchemie, Estonia

4月 2024 - 現在

Postdoc fellow

Umeå University

9月 2022 - 現在

PostdoctoralResearcher

University of Umeå

9月 2022 - 2月 2024

学歴

PhD (Neurosciences)

University of Tartu

- 現在

PhD | Neuroscience

University of Tartu, Estonia

1月 2012 - 3月 2022

Master (Biotechnology )

Tampere University of Technology

9月 2008 - 11月 2011

Bioengineering

Tampere University of Technology, Finland

9月 2008 - 10月 2011

Biotechnology

University of Malakand, Pakistan

8月 2002 - 2月 2007

認定資格

• Introduction to Health Writing

  Health Write Hub

  5月 2023 - 現在

• Certificate Course in Veterinary Pharmacovigilance

  PV Drug Safety Academy

  https://www.udemy.com/certificate/UC-3b0b06d0-9042-4df1-8e52-304031dfca12/

  9月 2025 - 9月 2025

• Signal Detection and Management in Pharmacovigilance

  PV Drug Safety Academy

  https://www.udemy.com/certificate/UC-a36bd308-68be-4fdd-b276-7c998f0639e6/

  9月 2025 - 9月 2025

• Introduction to pharmacovigilance

  Pharm Uni

  https://pharmuni.com/certificates/validation

  9月 2025 - 9月 2025

• Basics of Pharmacology and Drug

  udemy

  https://www.udemy.com/certificate/UC-52c57fb2-806f-4035-a080-e182e9292cb7/

  9月 2025 - 9月 2025

出版物

JOURNAL ARTICLE

Zeb, Akbar, Choubey, Vinay, Gupta, Ruby, Veksler, Vladimir, Kaasik, Allen (2022). Negative feedback system to maintain cell ROS homeostasis: KEAP1-PGAM5 complex senses mitochondrially generated ROS to induce mitophagy .

Vinay Choubey, Akbar Zeb, Allen Kaasik (2021). Molecular Mechanisms and Regulation of Mammalian Mitophagy . Cells.

Vinay Choubey, Akbar Zeb, Allen Kaasik (2021). Molecular Mechanisms and Regulation of Mammalian Mitophagy .

Akbar Zeb, Vinay Choubey, Ruby Gupta, Malle Kuum, Dzhamilja Safiulina, Annika Vaarmann, Nana Gogichaishvili, Mailis Liiv, Ivar Ilves, Kaido Tämm, et al. (2021). A novel role of KEAP1/PGAM5 complex: ROS sensor for inducing mitophagy .

Michal Cagalinec, Mailis Liiv, Zuzana Hodurova, Miriam Ann Hickey, Annika Vaarmann, Merle Mandel, Akbar Zeb, Vinay Choubey, Malle Kuum, Dzhamilja Safiulina, et al. (2016). Role of Mitochondrial Dynamics in Neuronal Development: Mechanism for Wolfram Syndrome .

Kemppainen, Kia K., Rinne, Juho, Sriram, Ashwin, Lakanmaa, Matti, Zeb, Akbar, Tuomela, Tea, Popplestone, Anna, Singh, Satpal, Sanz, Alberto, Rustin, Pierre, et al. (2013). Expression of alternative oxidase in Drosophila ameliorates diverse phenotypes due to cytochrome oxidase deficiency .

Sanz., A., Soikkeli, M., Portero-Otin, M., Wilson, A., Kemppainen, E., McIlroy, G., Ellila, S., Kemppainen, K. K., Tuomela, T., Lakanmaa, M., et al. (2010). Expression of the yeast NADH dehydrogenase Ndi1 in Drosophila confers increased lifespan independently of dietary restriction .

OTHER

Safiulina, Dzhamilja, Kuum, Malle, Choubey, Vinay, Gogichaishvili, Nana, Liiv, Joanna, Hickey, Miriam A, Cagalinec, Michal, Mandel, Merle, Zeb, Akbar, Liiv, Mailis, et al. (2018). Miro proteins prime mitochondria for Parkin translocation and mitophagy .