Mohammed AlQazlan
Riyadh,SA
Summary
Regional regulatory affairs and pharmacovigilance leader with over 9 years in the pharmaceutical and medical device sectors. Promoted to cluster lead in January 2026, overseeing regulatory and pharmacovigilance activities across 16 countries. Currently managing a team of 9 professionals and a diverse portfolio of 313 products, including 290 medical devices and 23 pharmaceuticals. Recognized for enhancing regulatory governance and driving sustainable business growth while ensuring compliance and patient safety.
Overview
2
2
Languages
1
1
Certification
6
6
years of post-secondary education
9
9
years of professional experience
Work history
Cluster Lead – Drug Pre & Post Market
Fresenius Medical Care
Riyadh, Riyadh Region
2026.01 - Current
- Directed a regional team of 9 regulatory affairs and pharmacovigilance professionals.
- Owned strategic oversight for a portfolio of 313 healthcare products.
- Set regulatory strategy direction with executive leadership for commercial growth.
- Earned promotion to cluster lead in January 2026 for leadership.
- Drove stronger pharmacovigilance governance and post-market compliance across the cluster.
- Controlled regulatory leadership for localisation initiatives and technology transfer activities.
- Chaired stakeholder engagement with health authorities and internal functions to resolve compliance.
- Coordinated cross-functional delivery across regulatory affairs quality medical supply chain and commercial teams.
Scientific Office Manager
Fresenius Medical Care
Riyadh, SA
2024.06 - Current
- Manage 290 regulatory lifecycles for pharmaceutical products and medical devices in Saudi Arabia.
- Ensure pharmacovigilance post-market surveillance compliance and vigilance reporting requirements..
- Lead regulatory strategy for new registrations, renewals, variations, and lifecycle management.
- Support local manufacturing submissions and technology transfer projects.
- Advise executives on regulatory risks and strategic opportunities.
Regulatory Affairs Manager
Olayan Group
Riyadh, SA
2023.04 - 2024.06
- Managed end-to-end regulatory affairs for 26 manufacturing sites for SFDA compliance.
- Led registrations, renewals, and variations across medicinal products, devices, and cosmetics.
- Supervised 3-persons regulatory team, balancing workloads to meet submission deadlines.
Quality Assurance & Regulatory Affairs Assistant Manager
Olayan Group
Riyadh, SA
2021.04 - 2023.03
Quality Assurance & Regulatory Affairs Supervisor
Olayan Group
Riyadh, SA
2019.04 - 2021.03
Quality Assurance Officer
SITCO Pharma
2017.10 - 2019.08
Education
Doctor of Pharmacy - Pharmacy
Qassim University
Buraidah, Al-Qassim Region 2011.01 - 2017.01
Skills
- Market access and regulatory intelligence
- Lifecycle management for products
- Signal detection in pharmacovigilance
- Risk assessment and post-market monitoring
- UDI compliance and vigilance processes
- Pharmaceutical registration and renewal processes
- Importation regulations adherence
- Leadership in people management
- Cross-functional team leadership and strategy formulation
- Business continuity planning for local manufacturing operations
- Expertise in technology transfer
Accomplishments
- Awarded Best Regulatory Affairs Leader – Europe & Middle East Region, Fresenius Medical Care (2026), recognizing outstanding leadership, regulatory excellence, and strategic contribution to business growth across the region.
- Recognized as Employee of the Year – Middle East Region, Fresenius Medical Care (2025), in appreciation of exceptional performance, leadership, and significant contributions to organizational success.
- Successfully achieved the registration and approval of Fresenius Medical Care’s pharmaceutical manufacturing production line with the Saudi Food and Drug Authority (SFDA) in 2024, enabling local manufacturing operations and supporting strategic localization objectives in Saudi Arabia.
- Graduated from the Olayan Management Development Program (November 2022), strengthening leadership, management, and strategic business capabilities.
- Awarded Olayan Pandemic Hero (May 2021) for exceptional commitment, dedication, and contribution during the COVID-19 pandemic.
Languages
English
Fluent
Arabic
Native
Certification
- Quality Management & Business Performance
- Managing Virtual/Remate Teams
- Organization Planning and Development for the 6a Blackbelt
References
References available upon request.
Courses
- Quality Management & Business Performance
- Managing Virtual/Remote Teams
- Organization Planning and Development for the 6σ Black Belt
Regulatory Success
- Since 2017, I've registered the following at SFDA:
- +25K MD models
- +50 Cosma Products
- 9 Medicinal Products
- +70 AR licenses
- 19 MDELs
- +60 Saber EOC
- +50 Classification Requests
Timeline
Cluster Lead – Drug Pre & Post Market
Fresenius Medical Care
2026.01 - Current
Scientific Office Manager
Fresenius Medical Care
2024.06 - Current
Regulatory Affairs Manager
Olayan Group
2023.04 - 2024.06
Quality Assurance & Regulatory Affairs Assistant Manager
Olayan Group
2021.04 - 2023.03
Quality Assurance & Regulatory Affairs Supervisor
Olayan Group
2019.04 - 2021.03
Quality Assurance Officer
SITCO Pharma
2017.10 - 2019.08
Doctor of Pharmacy - Pharmacy
Qassim University
2011.01 - 2017.01