Mahmoud Elshenawy
Senior R&D Researcher
El Obour
Summary
Dynamic Senior R&D Researcher at Eva Pharma with expertise in formulation development and regulatory compliance. Proven ability to lead cross-functional teams, enhance product stability, and optimize drug release profiles. Strong problem-solving and communication skills drive successful market approvals in emerging markets and Europe, ensuring adherence to international standards. Recognized for effective communication and problem-solving abilities in high-pressure environments.
Overview
6
6
years of professional experience
10
10
Certifications
2
2
Languages
Work History
Senior R&D Researcher
"Acting as Senior Regulatory Affairs Specialist"
Al Haram, Giza
01.2025 - Current
- Preparing and reviewing Module 2 (CTD), Module 3 (Quality) and Module 5 documentation to support market approval in emerging regions.
- Coordinating with internal stakeholders to ensure all required data and information are compiled and presented clearly and consistently.
- Collaboration with cross-functional teams, such as regulatory affairs, quality assurance, and quality control, to gather and analyze data, draft comprehensive technical documents, and prepare submissions that meet local regulatory requirements.
- Ensuring compliance with both regional and global regulatory standards and providing regulatory expertise on market entry strategies.
- Managing timelines and deliverables for multiple concurrent submissions to ensure deadlines are met.
- Monitoring regulatory changes and advising internal teams on necessary document updates to ensure ongoing compliance.
Senior R&D Researcher
Eva Pharma
Al Haram, Giza
03.2024 - 12.2024
- Leading the formulation development of immediate release, extended release and effervescent tablets to ensure optimal release profiles and bioavailability while maintaining stability and patient compliance.
- Designing and developing single and double-layer tablet formulations, with a focus on achieving targeted drug release rates and compatibility of active pharmaceutical ingredients (APIs) with excipients.
- Collaborating with cross-functional teams, including analytical development, quality control, quality assurance and regulatory affairs to ensure formulations are compliant with international regulatory standards, particularly for markets in KSA and Europe.
- Utilizing a variety of excipient systems, coating technologies, and manufacturing techniques to achieve the desired product characteristics while maintaining cost-effectiveness.
- Conducting process validation studies, including designing and executing validation protocols, to ensure that manufacturing processes are robust, reproducible, and compliant with international quality standards.
- Contributing to the preparation of regulatory submissions and technical documentation for market approval in KSA and Europe, ensuring all necessary data is provided to support successful product registrations.
- Engaging in troubleshooting and problem-solving during formulation development to address issues related to product performance, stability, and manufacturability.
- Responsible for purchasing, stocking and managing lab safety tools and PPE in the R&D department.
R&D Researcher
Eva Pharma
03.2022 - 02.2024
- Analysis of R&D trials, production batches, pilot and stability batches.
- Carrying out IVD studies “In vitro dissolution profile studies”.
- Oversee the validation of new R&D trials, ensuring all methodologies and results adhere to established guidelines and regulations.
- Conduct data analysis and interpret findings to provide actionable insights for product development.
- Perform detailed reviews of trial data, identifying patterns, discrepancies and potential areas for process optimization.
- Experienced in dealing with various devices such as HPLC devices” Waters & Agilent”, dissolution devices and GC.
- Support the documentation and reporting of trial results, maintaining comprehensive records for future reference and compliance audits.
- Continuously assess new technologies and industry trends to incorporate into validation processes for enhanced accuracy and efficiency.
- Conducting formulation studies, including stability testing, dissolution profiling, and scaling up to pilot and commercial batches to ensure the products meet both internal quality standards and regulatory guidelines.
- Responsible for purchasing, stocking and managing lab safety tools and PPE for the R&D team.
Night Shift Manager
Mahmoud Ismail Pharmacy
03.2019 - 03.2022
- Supervise and manage pharmacy operations during night shifts, ensuring the timely and accurate dispensing of medications.
- Lead and train night shift pharmacy staff, ensuring adherence to all safety protocols and best practices.
- Provide professional pharmaceutical advice and counseling to patients regarding prescription medications, over-the-counter drugs, and health concerns.
- Maintain inventory levels, manage stock control, and coordinate the ordering of medications to prevent shortages.
- Collaborate with healthcare professionals, such as physicians and nurses, to ensure optimal patient care and medication management.
Production and QC Intern
AUG Pharma
08.2021 - 09.2021
- Conducted quality control tests on raw materials, in-process samples, and finished products to ensure compliance with pharmacological standards and specifications.
- Collaborated with the QC team to perform stability studies, analyze data, and prepare reports for regulatory submissions and audits.
- Supported the implementation of standard operating procedures (SOPs) for production processes, equipment maintenance and quality control testing.
- Participated in troubleshooting and resolving production issues, contributing to continuous improvement initiatives.
- Maintained accurate records of production and quality control tests, ensuring compliance with GMP and company documentation standards.
Medical Representative Intern
Denta Pharma
07.2021 - 07.2021
Medical Representative Intern
Eva Pharma
08.2020 - 09.2020
- Established strong relationships with healthcare professionals, resulting in increased trust and credibility for the organization.
- Analyzed market to identify new opportunities and strengthen relationships with hospitals, medical centers and primary provider physicians.
- Collaborated with sales team to manage the territory efficiently and effectively prioritizing visits to key healthcare providers and facilities.
Education
Bachelor of Pharmacy -
Ain Shams University
Cairo, Egypt 04.2001 -
Skills
Skilled in experimental procedures
Research methodologies
Critical evaluation
Proficient in Microsoft Word
Effective time management
Agility
Analytical problem solving
Effective communication
Certification
Work Smarter With Microsoft Word, Microsoft
Accomplishments
Have been Certified as the best student by the pharmaceutics and Industrial department of Ain Shams University.
Timeline
Work Smarter With Microsoft Word, Microsoft
03-2025
Senior R&D Researcher
"Acting as Senior Regulatory Affairs Specialist"
01.2025 - Current
Budgeting and Scheduling Projects, University of California, Irvine
12-2024
Initiating and Planning Projects, University of California, Irvine
09-2024
Emotional and Social Intelligence, University of California, Davis
08-2024
Senior R&D Researcher
Eva Pharma
03.2024 - 12.2024
Data Analysis Diploma, EYouth Academy
01-2024
R&D Researcher
Eva Pharma
03.2022 - 02.2024
Fundamentals of quality assurance, Eva Pharma
09-2021
Fundamentals of quality control, Eva Pharma
09-2021
Fundamentals of manufacturing process
09-2021
Production and QC Intern
AUG Pharma
08.2021 - 09.2021
Medical Representative Intern
Denta Pharma
07.2021 - 07.2021
Marketing basics, Sandoz Egypt
09-2020
Medical Representative Intern
Eva Pharma
08.2020 - 09.2020
Medical caravan
06-2019
Night Shift Manager
Mahmoud Ismail Pharmacy
03.2019 - 03.2022
Bachelor of Pharmacy -
Ain Shams University
04.2001 -
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