Hi, I’m
Shireen Mahmoud Hussien Fahmy
REGULATORY AFFAIRS SPECIALIST
New Cairo
Summary
Results-driven Regulatory Affairs professional with 10+ years of experience in leading global pharmaceutical companies (Organon, MSD, Abbott), supporting regulatory strategy, marketing authorizations, lifecycle management, and health authority engagement across Egypt Cluster (Egypt, Libya, Yemen) and the Levant region (Jordan, Lebanon, Iraq). Proven expertise in end-to-end regulatory submissions, labeling and compliance, SOP development, and cross-functional collaboration with commercial, supply chain, quality, and global teams. Recognized Labeling Lead for the Middle East Women’s Health portfolio and French West Africa region, leading QRD-compliant labeling, artwork workflows, and HA submissions. Highly effective in matrix environments, influencing without authority and delivering compliant, on-time approvals while ensuring business and supply continuity.
Overview
11
years of professional experience
Work History
Organon - Egypt
Regulatory Affairs Specialist
06.2025 - Current
Job overview
- Keep abreast of Egypt and Levant Cluster updates in regulations and attended meetings with the respective health authorities to advance Organon interests and influence the regulatory environment.
- Manage product renewals across the clusters, including planning, dossier compilation and regulatory submission ensuring quality, compliance and timely approvals.
- Assessed minor, major variations and price impact, planned submission and received approvals for LEI, Network and CMC variation manufacturing & other quality changes.
- Deliver regulatory intelligence and strategic risk mitigation for lifecycle and site-change initiatives, accelerating approvals and ensuring supply continuity through cross-functional alignment.
- Alignment with cross functional teams and internal stakeholders including logistics, packaging sites, global labeling, market access and marketing on impact assessment, action planning and implementation of post approval change.
- Led Egypt Reliance pathway track, to accelerate product network variation through reliance pathway for 9 SKU, project outcome acceleration of in market Supply within Egypt with reduced timeline.
- Manage Supply Alignment forum with demand, supply chain and Local packager to ensure uninterrupted supply and avoid product shortage.
- Owner Libya off license to on license switch project, change control assessment with CMC and Sites, updating regulatory systems and align on SKU sharing with ME markets.
- Regulatory Affairs Specialist June 2025- Present Egypt and Levant Cluster (Jordan, Lebanon, Iraq) Libya and Yemen Regulatory Lead
Organon - Egypt
Regulatory Affairs Specialist
02.2021 - 06.2025
Job overview
- New Product launch Lead developing regulatory strategies and design a process for New market authorization application submission, approval within timelines to ensure alignment with the launch plan.
- Ensured alignment between all involved cross-functions stake holder including Market access, commercial, marketing, distribution and distribution, ensure consistency in meeting the targeted launch dates.
- Libya NPL lead E2E portfolio prioritization, submission planning and approval of 21 Marketing Authorization.
- Medical device registration strategy planning, registration, follow up on registration process, HA queries and Approvals.
- Developed and executed strategic plans for Organon Egypt and Yemen variation Spin-off Activities and life cycle management coordinated with Global RA, Quality, Supply Chain, and Marketing teams to align regulatory and operational requirements.
- Managed implementation timelines and post-approval commitments resolving regulatory gaps and optimizing processes.
- Acted as the primary point of contact for local Health Authorities, addressing queries and ensuring compliance throughout the spin-off.
- Variation -Supply Alignment Lead, track and manage variation E2E process, submission, Approval, artwork and packaging changes and AW flow approval and system update to ensure regulatory compliance; manage/mitigate supply constraints; Manage inventory builds where required, minimizing finished goods and component discard.
- Renewal planning, submission file compiling and Approval follow up with the HA different Departments.
- Distributor management establishing a mutual relationship with Libya and Yemen distributors.
- Regulatory Affairs Specialist – Egypt Libya and Yemen Regulatory Lead FEB 2021- June 2025
- Assignments: Labeling Assignment Tunisia, Morocco and Algeria labeling lead (Dec -2024 till present) Women Health Portfolio labeling lead ME (Jan 2024 till present)
- Established and implemented a regional labeling system, standardizing process and ensuring timely compliant submissions of SLU with local health authority requirements
- E2E labeling process coordination QRD (preparation ,review , Approval )initiating GLAMS System flow (mockup/protocol flow ) ensuring flow approval within the time line and HA Submission with in the leaflet priority timelines.
MSD - Egypt
Regulatory Affairs Specialist
03.2019 - 02.2021
Job overview
- Renewal Excellence lead Successfully approving 12 SKU under renewal
- New Product launch and registration
- Product life cycle management
- Control timelines (Submission, Approval and implementation with full alignment with the business plan
- Co-operate transversally with internal and external Stakeholder to reach company common Goal
- Regulatory Affairs Specialist March 2019-Feb 2021 Egypt Cluster (Egypt and Yemen)
Abbott - Egypt
Regulatory Affairs Specialist
06.2017 - 03.2019
Job overview
- Review and prepare registration packages and maintain registration license for pharmaceutical and biological products.
- Successfully setting registration strategy and alignment with different functions for new product launches and under license products and supported in registration process.
- Analysis Follow up NODCAR and NORCB
- Support supply and plan for stock control.
- Worked closely with Third party manufacturers to maintain registration licenses and manufacturing.
- Support Market Access in pricing strategy and product prioritization for Repricing file submission and HA follow up.
- Regulatory Affairs Specialist –June2017 – March 2019
MSD - Egypt
Regulatory Integration Officer
09.2014 - 06.2017
Job overview
- Sales and Marketing Coordinator
- CTC Customer Representative
- Regulatory Integration Officer Sept 2014-June 2017
- Sales and Marketing Coordinator Nov 2011- Sept 2014
- CTC Customer Representative Dec 2010 – Nov 2011
Education
Rome Business School
MBA-Management
01.2018
German University in Cairo
Bachelor of pharmaceutical science and Biotechnology
06.2010
Skills
Regulatory Strategy & Execution
Marketing Authorization & Lifecycle Management
Health Authority Engagement
Labeling & Artwork Compliance (QRD)
New Product Launch Support
Cross-Functional Leadership
Regulatory Intelligence & Risk Management
Project Management & Execution
Accomplishments
- Fast-track to market via Egypt Reliance Pathway; received Enhance Enterprise Efficiency Award – Dec 2025.
- Egypt PV Audit RA Support- Nov 2025
- Digital Tool received Bring your fire Sep-2026
- Reliance pathway achievement-received own it accountability and integrity Sep-2025
- ME SKU optimization received Thrive June 2025
- ME shared pack received Rise together June 2025
- GAIA variation strategy received rise together April 2025
- Renewal Excellence KPI improvement -own it accountability and integrity Dec 2024
- NPL Libya new market authorization -received Own it - Accountability and Integrity June-2022
- Glams change Agent Keep moving – May 2022
- Supply Risk mitigation April 2021
- Award of special achievement for outstanding performance - Aug 2016
Timeline
Regulatory Affairs Specialist
Organon - Egypt
06.2025 - Current
Regulatory Affairs Specialist
Organon - Egypt
02.2021 - 06.2025
Regulatory Affairs Specialist
MSD - Egypt
03.2019 - 02.2021
Regulatory Affairs Specialist
Abbott - Egypt
06.2017 - 03.2019
Regulatory Integration Officer
MSD - Egypt
09.2014 - 06.2017
Rome Business School
MBA-Management
German University in Cairo
Bachelor of pharmaceutical science and Biotechnology