Lina AlShehri
Riyadh,Saudi Arabia
Summary
A Licensed pharmacist with a doctor of pharmacy degree (PharmD). skilled in communication, analytics, and problem-solving. Passionate about pharmaceutical sciences and regulatory affairs field. Engaged in various successful pharmaceutical projects and research. Committed to ongoing career growth and achievement.
Overview
2
2
years of professional experience
Work history
Regulatory Affairs Associate
Hikma Pharmaceuticals Company
09.2023 - Current
- Maintain up-to-date knowledge on international and domestic regulatory requirements.
- Compile of product technical file documentation and provide correct and accurate technical review of data or reports, according to SFDA requirements, for drug new submissions, renewal applications, and variation applications.
- Ensure all company products comply with SFDA regulations.
- Ensure timely submissions as well tightly manage deficiency responses.
- Monitor and interpret regulations to evaluate their impact on the business.
- Assist in preparing responses to regulatory authorities' questions within assigned timelines.
Trainee in Procurement Department - Internship
National Unified Procurement Company (NUPCO)
05.2023 - 06.2023
- Trained in Direct Purchasing department, undergoing comprehensive training in procurement processes
Pharm.D Intern
Ministry of National Guard Health Affairs (MNG-HA)
07.2022 - 05.2023
- Internal Medicine Rotation, Inpatient Pharmacy Rotation, Intensive Care Unit Rotation, Quality Assurance Rotation, Outpatient Pharmacy Rotation
Trainee in Quality Department - Internship
Saudi Food and Drug Authority (SFDA)
11.2022
- Trained and participated on quality evaluation of innovative medicines to seek marketing authorization
Education
Doctor of Pharmacy (Pharm.D) -
King Saud Bin Abdulaziz University for Health Sciences
Skills
- Communication skills
- Analytical skills
- Critical thinking
- Problem-solving
- Leadership
- Time management
Languages
Arabic
Native
English
Fluent
References
References available upon request.
Research and Publications
- Assessing the Prevalence and Characteristics of Self-reported Penicillin Allergy in Saudi Arabian Population: A Nationwide Cross-sectional Study
-Published in Saudi Journal of Infectious Disease:
https://doi.org/10.1016/j.jsps.2022.12.006
- Comparative Effectiveness of Apixaban and Rivaroxaban Lead-in Dosing in VTE Treatment: Observational Multi-Center Real-World Study
-Published in Journal of Clinical Medicine: https://doi.org/10.3390/jcm12010199
- Lyophilized multicomponent solid dispersions enhanced chrysin biopharmaceutical attributes and anticancer activity - Ongoing research
Timeline
Regulatory Affairs Associate
Hikma Pharmaceuticals Company
09.2023 - Current
Trainee in Procurement Department - Internship
National Unified Procurement Company (NUPCO)
05.2023 - 06.2023
Trainee in Quality Department - Internship
Saudi Food and Drug Authority (SFDA)
11.2022
Pharm.D Intern
Ministry of National Guard Health Affairs (MNG-HA)
07.2022 - 05.2023
Doctor of Pharmacy (Pharm.D) -
King Saud Bin Abdulaziz University for Health Sciences
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