DR
Dalya Rizk
Global Regulatory Affairs Associate at Mohammed Alkhuraiji Industrial Company (Apple Pharma)
EgyptWork Experience
Global Regulatory Affairs Associate
Mohammed Alkhuraiji Industrial Company (Apple Pharma)
Jan 2023 - Present -2 yrs, 3 months
Saudi Arabia
- Job Details:Executing regulatory activities related to registration requirements (new submissions, renewals, products lifecycle maintenance, variations). Responsible for communication and liaison with local/global health authorities (SFDA – GCC health authorities) for all regulatory affairs and registration activities follow-up. Reviewing product promotional materials, labels, batch records, specification sheets, and test methods for compliance with applicable regulations and policies.
Global Regulatory Affairs Supervisor
Middle East Pharmaceutical Industries Co. (Avalon Pharma)
Dec 2017 - Dec 2022 -5 yrs
Saudi Arabia
- Job Details:Preparation, executing and leading regulatory affairs team for all regulatory activities related to registration requirements (new submissions, renewals, products lifecycle maintenance, variations) in body authorities across multiple regions.
Sedico Pharmaceutical Co. (South Egypt Drug Industries Company)
Jan 2010 - Nov 2017 -7 yrs, 10 months
Egypt
- Job Details:Leading regulatory affairs team for preparing and reviewing regulatory submissions in body authorities across multiple regions.
Sedico Pharmaceutical Co. (South Egypt Drug Industries Company)
Dec 2002 - Dec 2010 -8 yrs
Egypt
- Job Details:Preparing registration dossiers for local and global submissions in body authorities across multiple regions.
Education
Bachelor's Degree in Pharmaceutical Science
Zagazig University (ZU)Jan 2002
Skills
- Project Management
- Documentation Management
- regulatory submissions
- CMC writing
- labeling
- Regulatory Strategy
- Problem-Solving
- Communication skills
- adaptation
- Negotiation
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Languages
English
FluentArabic
Fluent