Instructor
Dr. Zahra Hassan
Pharma industry expert
About me
A highly dedicated and detail-oriented Regional Regulatory Affairs Manager for the MENA Region, Europe, USA, LATAM, Brazil, and Asia, I bring over 16 years of comprehensive experience in the pharmaceutical industry. As a licensed pharmacist with global exposure, my career spans pharmaceuticals, general sale products, regulatory affairs, pharmacovigilance, compliance, and life-cycle management across multinational organizations.
My professional journey covers the full regulatory spectrum—including product registration, renewals, variations, contract management, aftermarket regulatory activities (PV), and cross-functional leadership. I have consistently supported organizations with strategic regulatory planning, multi-project management, and effective communication with Health Authorities, regulatory agencies, and global partners.
I possess strong experience in clinical and regulatory operations, as well as their integration with R&D, production, quality, market access, and product launch activities. I regularly deliver presentations, business proposals, training sessions, and regulatory strategies to internal teams and external partners.
My background also includes:
Technical expertise in medical device regulations, CTD/eCTD submissions, CMC, Quality Management Systems, and Post-Market Surveillance
Leading teams, mentoring juniors, and supporting onboarding processes
Implementing global and local SOPs aligned with META region requirements
Conducting PV training for field safety teams and ensuring proper safety reporting
Strong understanding of pharmaco-economics, risk assessment, complaints handling, pricing issues, and customs clearance challenges
Experience in QA, ISO 9001, ISO 13485, GMP, audits, CAPA, RPP/QPPV, and internal regulatory systems
Academically, I hold:
MSc in Pharmacovigilance
MSc in Pharmaco-Economics
RAP/RAC credentials
MOH License
I value continuous learning, constructive feedback, and collaborative problem-solving. My mission is to transform real-world regulatory and PV expertise into practical, accessible learning that empowers students to excel in their careers across the pharmaceutical and healthcare industries.