Profile Details

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Hire Rachid E.

Netherlands

USD 40 /hr

More than 5 years of experience as Regulatory Affairs Specialist

Profile Summary

My qualification is an MSc in Biomedical Sciences. I am a Regulatory Affairs Specialist. The primary responsibilities are: - Working with CTD dossier - Coordination of the project (compilation and binding of the regulatory dossiers for the new application of marketing authorisation/renewal/variation; submission of products registration application; literature review; labelling & artwork) - Preparing new CMC applications for marketing authorisation/renewal/variation of medicinal products, OTC and medical devices for regulatory submission - Regulatory consulting related to EU/US regulation - Adhere to required use of technical resources, through the use of work practices and QC/QA regimes, to maintain regulatory and internal compliance. What can I do for you? - Pharmaceutical Regulatory Affairs Projects. - Some of my other specialties include technical writing to product submissions/dossiers. I can assist you with your drug label development and/or editing to ensure you are compliant to your jurisdiction. - My favorite thing is label compliance review! I can review your pharmaceutical and OTC drug labels for compliance to US FDA, EU Directives, Health Canada and more! Do not hesitate to contact me to discuss potential collaborations. I am looking forward to hearing from you!

Subject Matter Expertise

• ★ Pharmaceutical Regulatory Affairs
• ★ Regulatory Affairs
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Pharmaceutical Process Development
• ☆ Clinical Trials
• ☆ Pharmaceutical Technology
• ☆ Regulatory Writing
• ☆ CMC Documentation

Services

• Writing
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Consulting Regulatory Consulting, Manufacturing Consulting

Product Development Manufacturing, Product Compliance

Work Experience

Regulatory Affairs Specialist

Clinmed Pharma

January 2018 - Present

Education

MSc

University of Greenwich

October 2017 - August 2019

Certifications

• Responsible Person

  Pharmatec

  May 2022 - Present

Publications

ONLINE RESOURCE

Rachid El Khouly (2023). Abstract - Risk Assessment, Bioethics, and Project Management in Pharmacy .

Rachid El Khouly (2023). Bacteria fighting for their lives: the bacterial / pharmaceutical evolutionary race .

Rachid El Khouly (2023). Risk Assessment, Bioethics, and Project Management in Pharmacy .

Rachid El Khouly (2023). Treatment of Nasal Methicillin-Resistant Staphylococcus aureus by Ciprofloxacin: A Case Report .

CONFERENCE POSTER

Rachid El Khouly (2023). The Benefits of Patient Blood Management .

(2018). The Benefits of Patient Blood Management . Unpublished. Unpublished

PREPRINT

Rachid El Khouly(2022). Risk Assessment, Bioethics, and Project Management in Pharmacy . Unpublished

Rachid El Khouly(2019). Bacteria fighting for their lives: the bacterial / pharmaceutical evolutionary race . Unpublished

CONFERENCE ABSTRACT

Rachid El Khouly(2022). Abstract - Risk Assessment, Bioethics, and Project Management in Pharmacy . Unpublished

REPORT

Rachid El Khouly(2019). Treatment of Nasal Methicillin-Resistant Staphylococcus aureus by Ciprofloxacin: A Case Report . Unpublished