AHMED IBRAHIM HELAL
Apex,USA
Summary
Regulatory affairs manager with 12 years of experience developing and implementing strategies that achieve compliance with government regulations across the region. Well versed in managing cross functional teams, building relationships with key stakeholders, and communicating complex information in a clear and concise manner.
Overview
21
21
years of professional experience
Work History
Regulatory Affairs Manager
Alcon
Cairo, Egypt
04.2023 - Current
- Proposing regulatory strategies for new product launches and preparing regulatory submissions to HAs
- Coordinate with Global RA team and R&D team for regulatory strategy development for our new innovative products
- Regulatory follow up with Distributers and HA representative for timely registration
- Organizing and moderating Alcon Manufacturing site inspection visits by different HAs.
Regulatory Affairs Specialist
Alcon
Cairo, Egypt
04.2021 - 03.2023
- Proposing regulatory strategies for new product launches and preparing regulatory submissions to HAs
- Coordinate with Global RA team and R&D team for regulatory strategy development for our new innovative products
- Regulatory follow up with Distributers and HA representative for timely registration
- Successful Alcon Manufacturing site inspection visits by different Has (Ghana, Libya and Kenya)
- Creating strong relationships globally with partners and key customers to develop and execute regulatory plans in support of mutual goals and objectives for Alcon
- Performance Award in 2022.
Regulatory Affairs Executive
Boehringer Ingelheim, LINEA
Cairo, Egypt
12.2020 - 04.2021
- Preparation, compilation and submission of Respiratory and specialty portfolio submission dossier complying with the
- EU/USFDA guidance in Egypt, Jordan, Lebanon and Iraq
- Post approval submissions and Life Cycle management in LINEA cluster for Respiratory and specialty portfolio
- Responding to HA queries from HAs
- Providing a regular insights and regulatory strategy to different stakeholders
- Cluster Artwork (FB, Leaflet) reviewer.
Regulatory Affairs Specialist
Novartis Pharma AG
Cairo, Egypt
06.2015 - 11.2020
- Manage up to 100 of Novartis products in Sudan
- Execute all regulatory process and changes according to the cluster plan for Oncology portfolio in English East
- Africa Cluster
- Monitor and keep regulatory data related to healthcare and competitive marketplace, client portfolio, commercial interest and other regulatory affairs matter as necessary up to date
- Distributer activities manager
- Management of HA communication
- Constant collaboration with supply chain, quality and commercial team for logistics planning to ensure continuity and timely manner entry of stock
- Global RA project Coordinator
- (Latin America and Canada)
- First Quality award in Africa
- Collaboration award for EEA Cluster.
Quality Assurance/ Regulatory Affairs manager
RAY CRO Organization
Cairo, Egypt
02.2014 - 05.2015
- Documentation, SOPs issuing, and reviewing
- Preparing
- Compiling and submitting CTD files
- Internal and external audits planning , follow up and closing
Regulatory Affairs Compliance Associate
Novartis Pharma AG
Cairo, Egypt
02.2012 - 02.2014
- Provided support to all regulatory and compliance activities in Ethiopia, Malawi, Mozambique, Sudan, Zambia and Zimbabwe
- Regulatory data integrity reviewer in Novartis Database
- Distributer activities manager
- Management of HA communication.
Quality Assurance Senior
Egyptian International Pharmaceutical Industries Company, EIPICO
Ramadan City, Egypt
05.2003 - 02.2012
Project manager
East
Internal auditor
- QA in solid dosage form department
- Quality Assurance officer in different industrial areas including the Non Sterile Antibiotics Department; (b) Work in liquid & suspension filling sterile area
- (c) Work in Syrups / Suspensions Department
- (d) Work in Ointments / Suppositories / Aerosols Department.; (e) Work in Tablets and Solid Dosage Forms department
- Production Pharmacist in Biotechnology Department
- Oversaw manufacturing, filling & packaging lines of pharmaceutical products; sampling process & In Process
- Control (IPC)
- Developed significant expertise in batch records review
- Acquired expert knowledge about the principles of Good Manufacturing Practice (GMP) and the International
- Organization for Standardization (ISO 9000 & ISO 14001) requirements.
Education
PhD - Industrial Biotechnology (Biochemistry
GEBRI Institute, Sadat University, Cairo University
05.2015
AUC 2- Statistical Quality Control 3- Planning of Top Quality; -
01.2011
MSc - Microbiology and Immunology
Cairo University
05.2010
BSc - Pharmaceutical Science
05.2001
Total quality management (TQM) diploma -
Total Quality Management Certification - Quality
The American University in Cairo
Cairo, NYM.S - Helal World applied science
Skills
- Problem-Solving
- Project Management
- Compliance Enforcement
- Technical Analysis
- Strategic Planning
- Project Lifecycle
Languages
- Arabic (native); English (Proficient); Dutch (basic).
- Post-Graduate
Timeline
Regulatory Affairs Manager
Alcon
04.2023 - Current
Regulatory Affairs Specialist
Alcon
04.2021 - 03.2023
Regulatory Affairs Executive
Boehringer Ingelheim, LINEA
12.2020 - 04.2021
Regulatory Affairs Specialist
Novartis Pharma AG
06.2015 - 11.2020
Quality Assurance/ Regulatory Affairs manager
RAY CRO Organization
02.2014 - 05.2015
Regulatory Affairs Compliance Associate
Novartis Pharma AG
02.2012 - 02.2014
Quality Assurance Senior
Egyptian International Pharmaceutical Industries Company, EIPICO
05.2003 - 02.2012
Project manager
East
Internal auditor
PhD - Industrial Biotechnology (Biochemistry
GEBRI Institute, Sadat University, Cairo University
AUC 2- Statistical Quality Control 3- Planning of Top Quality; -
MSc - Microbiology and Immunology
Cairo University
BSc - Pharmaceutical Science
Total quality management (TQM) diploma -
Total Quality Management Certification - Quality
The American University in Cairo
M.S - Helal World applied science
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