Biography

About the Instructor

Dr. Zahra Hassan Hussein Sobhy is a seasoned Regulatory Affairs and Pharmacovigilance expert with over 16 years of experience in the pharmaceutical industry across MENA, Europe, US, LatAm, and Asia. She specializes in global regulatory strategy, product lifecycle management, medical devices, PV, and compliance with international and regional health authority requirements.

Dr. Zahra brings a rare combination of strategic regulatory thinking, hands-on dossier preparation, and cross-functional leadership experience. Her work spans pharmaceuticals, nutraceuticals, and medical devices, with a focus on fast-track product registrations, regulatory intelligence, and PV system implementation. She has successfully managed regulatory teams, built PV departments from the ground up, and led regional expansions while ensuring compliance with global and local regulatory frameworks.

At PharmaCores, Dr. Zahra’s courses help learners translate regulatory knowledge into actionable industry skills, providing practical guidance on registration strategy, PV operations, dossier management, and risk assessment. Her teaching emphasizes real-world regulatory decision-making, preparing professionals to navigate complex compliance environments confidently.

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Education

• Master of Science in Pharmacovigilance – Bordeaux University, France (2020)

• Master of Science in Pharmaco-Economics – Barcelona School of Business, Spain (Ongoing)

• MBA – Chifley Business School (2013)

• Dual Diploma in Regulatory Affairs – RAP Society, USA (2013)

• Bachelor of Science in Pharmacy – Ain Shams University, Cairo, Egypt (2005)

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Professional Experience

• QA/Regulatory Affairs & PV Manager – MENA/EMA/Brazil/USA – DermaPenWorld, Dubai, UAE (2025–Present)

  • Oversaw regional regulatory strategy, product registration, lifecycle management, and pharmacovigilance operations.

  • Led cross-functional teams to ensure compliance with global (EMA, FDA, ICH) and regional regulatory standards.

  • Built and managed the regional PV department, implementing SOPs and training junior staff.

• QA/Regulatory Affairs Manager – MENA/META Region – Cooper International, Dubai, UAE (2024)

  • Developed regulatory strategies, coordinated submissions and renewals, and ensured regulatory compliance for new and existing products.

• QA/Regulatory Affairs Manager – MENA/META Region – Fidia Pharmaceutica, Dubai, UAE (2017–2023)

  • Managed product registrations, PV activities, and lifecycle management across multiple countries.

  • Led internal PV audits, local RMP implementations, and coordination with distributors.

• QA/Regulatory Manager – GCC Region – EIPICO, Dubai, UAE (2010–2013)

  • Implemented regulatory strategies and oversaw compliance, labeling, packaging, and submissions to local health authorities.

• Regulatory Affairs Officer / Key Account Manager – UAE/KSA Markets – Yomaya Medical Trading (2007–2010)

  • Managed regulatory submissions and market access, achieving multiple product registrations and account expansions.

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Areas of Expertise

• Regulatory Affairs Strategy & Compliance (Pharmaceuticals, Nutraceuticals, Medical Devices)

• Pharmacovigilance (PV) System Implementation & Signal Detection

• Product Lifecycle Management & Registration Planning

• Dossier Preparation, Submissions & Health Authority Interactions

• Risk Assessment & Strategic Regulatory Thinking

• Team Leadership, Coaching & Training

• Cross-functional Collaboration with R&D, Quality, Manufacturing & Marketing

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Academic & Industry Contributions

• Established and expanded PV systems across MENA, Gulf, and Middle East regions

• Conducted PV and regulatory training programs for junior staff and field teams

• Successfully led over 20 new product registrations and therapeutic line expansions in MENA

• Implemented over 15 PV SOPs and managed submission of PSURs, RMPs, and ICSRs

• Contributed to strategic regulatory planning and local/global harmonization projects

Courses