MAGED FAWZY ABDEL KHALEK
R&D Regional Manager
Cairo
Summary
Accomplished pharmaceutical R&D leader with a proven track record in accelerating product development cycles, optimizing cost-effective operations, and driving business expansion in the generic pharmaceutical industry. Adept at leading innovation, regulatory compliance, and high-impact technical transfers to strengthen market presence. Visionary leadership in aligning R&D with corporate strategies, with a strong focus on “Right First Time” execution, Concentrate on developing Non-infringing formula/ Value-added medicines to enrich portfolio, and operational excellence.
Overview
24
24
years of professional experience
2024
2024
years of post-secondary education
2
2
Languages
Work History
R&D Regional Manager
SAJA Pharmaceuticals
07.2019 - Current
R&D Director and assigned Plant manager
Pharco B International
02.2019 - 06.2019
- Company Overview: Employer: Pharco B International, Egypt
- Managing all R&D activities including CTD preparation for export
- Employer: Pharco B International, Egypt
Export Regulatory Affairs Manager
Pharaonia Pharma
12.2016 - 09.2017
- Company Overview: Employer: Pharaonia Pharma, Egypt
- Managing all regulatory affairs activities in Export, including CTD submissions
- Employer: Pharaonia Pharma, Egypt
Independent trainer for CTD/eCTD submission
Reyada Pro-Egypt
07.2015 - 11.2016
- Company Overview: Employer: Reyada Pro-Egypt
- Giving in-depth training workshops on how to prepare trouble-free CTD/eCTD submissions
- This training was giving to 70 attendees from 17 local companies representing more than 70% of Egypt Exporters
- Employer: Reyada Pro-Egypt
Research and Development Manager
Egypharma
07.2015 - 11.2016
- Company Overview: Employer: Egypharma, Egypt
- Managing all activities in R&D; Analytical, Pharmaceutical, Package development, Scale up and technology transfer to wide range of products; injections, lyophilized products, solid products (including SGC) and semisolids
- Employer: Egypharma, Egypt
Research and Development Manager/ Deputy Technical Director
Deef Pharmaceutical Industries Company
02.2007 - 05.2015
- Company Overview: Employer: Deef Pharmaceutical Industries Company, Saudi Arabia
- Managing all activities in R&D; Analytical, Pharmaceutical, Package development, Scale up and eCTD compilation
- Member of technical committee (as deputy technical director) with the following responsibility; Updating Quality management system as per ICH Q10 guidelines, Support Qualification, Validation, and Calibration Activities of Equipment
- Lead Deviations Investigations using different tools (FMEA, Pareto analysis,…etc) and generate CAPA
- Bioequivalence protocol review and monitoring
- Pharmacovigilance monitoring (QPPV from July 2011 – July 2013)
- Patency related activities: Patent filing, developing non infringing formulae
- Pipeline committee: Analyzing market (Private, LPO, tenders), selecting candidate products
- Managing e-submission activities using Lorenz Docubridge and Extedo global validator (eCTD & NeeS)
- Leading track & trace project (initial phase)
- Employer: Deef Pharmaceutical Industries Company, Saudi Arabia
- Key achievements: Establishing state of art R&D department
- Developing, registration and launching more than 70 products
- Filing 5 patent applications in KACST/KSA and one in European Patent Office
- Establishing the pharmacovigilance system
- Good understanding of SFDA and GCC regulatory guidelines, fair understanding of US-FDA and EMA regulatory guidelines
- Managing variation filling and response to inquiries
- Passing audits by SFDA, GCC-DR and multinational companies (Sanofi, Bayer, Reckitt Benckiser, Actavis)
- Managing e-submission activities
R&D supervisor
Egyptian International Pharmaceutical Co.(EIPICO)
12.2000 - 01.2007
- Company Overview: Employer: Egyptian International Pharmaceutical Co.(EIPICO)/Egypt
- Developing various formulations (solid, semisolids and liquids, sterile)
- Employer: Egyptian International Pharmaceutical Co.(EIPICO)/Egypt
- Key achievements: Formulation and scale up of more than 50 products in various dosage forms
Education
ChatGPT Prompt Engineering -
DeepLearning AI
Generative AI Fundamentals - undefined
IBM
Diploma - Business Administration
Durham Univ.
Ph. D. - Enhancement of bioavailability of oral disintegrating miconazole tablets using foam granulation
Alazhar Univ.
M. Sc. - Development of rugged formula based on statistical analysis that can be upgraded from laboratory scale to full production scale
Alazhar Univ.
B. Sc. - Bachelor of Pharmacy
Tanta Univ.
Skills
- Pharmaceutical development
- Patency related activities
- Management skills
Operational management
- Analytical development
Business development and planning
Performance management
Affiliations
- Member of American Association of Pharmaceutical Scientists (AAPS)
- Member of Project Management Institute
Publications And Fellowships
- Formulation, evaluation and optimization of miconazole nitrate tablet prepared by foam granulation technique, International Journal of Drug Delivery (2011)
- Miconazole Nitrate Oral Disintegrating Tablets: In Vivo Performance and Stability Study, AAPS PharmSciTech (2012)
- Risperidone oral disintegrating mini-tablets; A robust-product for pediatrics, Acta Pharm. 65 (2015)
Personal Information
- Number of Children: 4
- Date of Birth: 04/20/77
- Nationality: Egyptian
- Marital Status: Married
Timeline
R&D Regional Manager
SAJA Pharmaceuticals
07.2019 - Current
R&D Director and assigned Plant manager
Pharco B International
02.2019 - 06.2019
Export Regulatory Affairs Manager
Pharaonia Pharma
12.2016 - 09.2017
Independent trainer for CTD/eCTD submission
Reyada Pro-Egypt
07.2015 - 11.2016
Research and Development Manager
Egypharma
07.2015 - 11.2016
Research and Development Manager/ Deputy Technical Director
Deef Pharmaceutical Industries Company
02.2007 - 05.2015
R&D supervisor
Egyptian International Pharmaceutical Co.(EIPICO)
12.2000 - 01.2007
Generative AI Fundamentals - undefined
IBM
Diploma - Business Administration
Durham Univ.
Ph. D. - Enhancement of bioavailability of oral disintegrating miconazole tablets using foam granulation
Alazhar Univ.
M. Sc. - Development of rugged formula based on statistical analysis that can be upgraded from laboratory scale to full production scale
Alazhar Univ.
B. Sc. - Bachelor of Pharmacy
Tanta Univ.
ChatGPT Prompt Engineering -
DeepLearning AI
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