Lina Albarghothi
Dubai,U.A.E.
Summary
Experience regulatory affairs professional with extensive expertise in regulatory compliance, medical device regulations, and pharmaceutical quality assurance. Proven track record in regulatory submission, pharmacovigilance, and GMP/cGMP principles. Adept at managing electronic CTD submissions, handling product recalls, and ensuring adherence to regulatory requirements. Skilled in records management procedures and product life cycle management. Committed to maintaining the highest standards of compliance and quality within the pharmaceutical industry.
Overview
11
11
years of professional experience
9
9
years of post-secondary education
1
1
Certification
Work History
Group Operation Manager (Regulatory, Quality & Legal) (MENA)
AG Holding Company
Dubai, UAE
08.2023 - 11.2024
- Led the submission of 45 product registrations across UAE MOH, DOH, ESMA, SFDA, JFDA, and EDA, achieving a 100% acceptance rate and reducing certification timelines for medical products, devices, supplements, and cosmetics by 20%, while ensuring compliance with META regulations.
- Developed, reviewed, and approved artwork for 20 new products, including medical devices, cosmetics, and supplements.
- Collected, organized, and maintained files on local, regional, and global RAQA intelligence, ensuring compliance with MDD, MDR, IVDR, IVDD, Cosmetics Regulations, Supplements, RoHS, and regional requirements in META.
- Identified the need for new regulatory procedures and SOPs, contributing to their development and successful implementation.
- Served as RAQA Leader, reporting performance, risks, and issues to local and senior leadership.
- Recruited, selected, and developed talent to enhance team performance and engagement.
- coordinate with third-party, Competent Authority, and Notified Body audits.
- Monitored compliance with GMP regulatory requirements and QA processes, addressing non-compliance issues effectively.
- Led the integration of new acquisitions, ensuring the alignment of RAQA systems within local offices and across META.
- Represented the organization in local industry associations and regulatory working groups across META as a subject matter expert.
- Collaborated with manufacturing and design divisions to align RAQA and commercial operations.
- Coordinated with health authorities to support commercial operations and supply chain management across META.
- Maintained an updated database for the active portfolio in the Middle East, Turkey, and Africa, ensuring accurate regulatory documentation and reporting.
Head of Access to Adherence and Homecare (Greater MENA)
Axios International
Dubai, UAE
01.2022 - 08.2023
- Pharmaceutical Project Leadership and Integration: Led 20 projects for BD, Novartis, Takeda, Roche, Sanofi, AbbVie, Amgen, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca, and GSK, customizing them as per each pharma regulatory, pharmacovigilance, compliance, and quality standards.
- Government Project Leadership and Integration: Designed and implemented 6 projects with public health and pharmaceutical authorities, including UAE MOH, DHA, and DOH, aligning objectives with regulatory standards to enhance healthcare initiatives.
- Health Campaign Execution and Compliance: Developed and managed 15 impactful health campaigns for HCV, diabetes, cancer, chronic disease adherence, and home care, ensuring full regulatory compliance.
- Operational Efficiency and Quality Improvement: Developed operational guidelines linked to regulatory requirements, improving efficiency while maintaining high compliance standards.
- Medical Team Leadership and Training: Recruited, trained, and managed over 40 healthcare teams across the MENA region, ensuring adherence to regulatory protocols and quality benchmarks.
- Clinical and Non-Clinical Operations Management: Monitored clinical operations for home care projects, HCP training, clinical audits, and VIP programs, while managing non-clinical activities like medication delivery with a focus on high-quality standards.
- Quality and Reporting Frameworks: Designed and implemented reporting frameworks for data collection, analysis, and follow-up, driving continuous quality improvement and compliance.
- Accreditation and Protocol Development: Led the development of JCI and GXP standards and clinical protocols, achieving compliance and improving patient safety.
- Customer Experience and Quality Monitoring: Enhanced medical and non-medical customer experiences, aligning service delivery improvements with regulatory and quality standards.
- Regulatory Coordination: Coordinated with UAE DHA, MOH, KSA SFDA, MOH Oman, and Kuwait MOH, ensuring compliance with local and regional regulations and streamlining approvals.
- Regulatory Leadership: Served as the regional point of contact for regulatory audits, ensuring compliance and Audit readiness.
- Risk Management and Clinical Governance: Developed and implemented risk management strategies and clinical governance frameworks.
- Complaint Resolution and Service Improvement: Managed complaint resolution processes, ensuring swift resolution and continuous service improvements.
Operational Cluster Lead and Greater MENA
Axios International
Dubai, UAE
01.2020 - 12.2021
- Develop Cluster Business Strategy (UAE, KSA, Oman, Bahrain): Align strategy with stakeholders, ensuring effective project management, monitoring, and compliance with regulatory and quality standards.
- Lead Specialization (Medication Adherence, Education, Remote Care, Digital Services): Manage and execute services in UAE & KSA, ensuring compliance with standards.
- Monitor 15 Running Programs (Biological & Oncology Medicine): Oversee program performance, ensuring regulatory and quality standards are met.
- Establish Charitable Pharmacy Chain: Develop and implement with adherence to DHA regulatory standards.
- Maintain Patient Project Profitability: Ensure financial health and profitability through regular monitoring and compliance as per each pharma standards
- Pass Regulatory Audits (UAE DHA & MOH): Lead audit preparation for pharmacy and home care services.
- Lead and Implement DUPHAT Awards: Manage participation and ensure event won best innovative Award.
Adherence Projects Manager
Axios International
Dubai, UAE
11.2017 - 12.2019
- Lead Pharmacovigilance and Clinical for All Company Audits: Manage and execute pharmacovigilance and clinical audits, ensuring compliance and successful outcomes.
- Maintain Biological Patient Education & Adherence Program (Novartis & Janssen): Led and ensured the success of patient education and adherence programs with Novartis and Janssen.
- Design Health Insurance Patient Programs: Develop and implement patient programs within health insurance frameworks, ensuring effective delivery.
- Manage Patient Programs: Oversee programs serving over 1,000 patients, ensuring smooth execution and compliance with healthcare standards.
- Founding Member of Internal Audit & CPR Communities: Contribute to the establishment and development of internal audit and CPR communities.
- Lead and Organize DUPHAT 2019 Patient Forum: Successfully organized the first patient forum at DUPHAT, achieving 100% patient attendance.
Medical Director
Life Pharmacy
Dubai, UAE
02.2017 - 09.2017
- Communicate and consult with doctors and nurses to improve patient treatment and update the doctors with newer medications in the market
- Supervise the ordering and safe storage of medical products
- Reviewing operations of the Pharmacy for compliance with policies, laws, and regulations
- Promoting sales and developing the business
- Supervising and dispensing medications and other pharmaceutical products
- Follow up with the register of controlled drugs for legal and stock control purposes
- Advising patients of any adverse side-effects of medicines or potential interactions with other medicines/treatments
- Manage inventory, maintain records, and prepare monthly reports
- Deal sensitively and confidentially with patient's needs effectively, both orally and in writing
- Maintain full control over delivering, stocking, and labelling medicine and other products and monitor their condition to prevent expiring or deterioration
- Establish and maintain effective working relationships with patients, other employees, and the public
- Provides training to Pharmacy students, training pharmacists and new D.H.A
- Pharmacist
Pharmacist
Super Care Pharmacies
Dubai, UAE
10.2014 - 06.2016
- Accurately dispensing drugs to patients according to a doctor's prescription
- Checking prescriptions for errors & making sure they are appropriate for patients
- Measuring, packaging, labelling, and recording medications issued to patients
- Answering questions from patients and staff about medicines
- Ensuring the accuracy of all prescriptions, products, and services supplied
- Helping to develop the Pharmacy's electronic discharge system
- Communicating with customers sympathetically and supportively
- Giving private consultations when required
- Maintaining pharmaceutical stock, creating inventories, and ordering more drugs
Insurance Medical Call Canter Agent
NEXTCARE TPA
Dubai, UAE
04.2014 - 09.2014
- Responsible for all medication, maternity, dental and optical approval with limited time and qualitative approval
- Responsible for receiving telephone calls and e-mails from members, answering member's inquiries and problem-solving with outstanding customer service
- Coordinate with the regional team on K.S.A., Lebanon, Qatar, Kuwait, and Egypt and provide all needed approval and inquiries with limited time and accurate information
- Experience on I.C.D
- 9 and 10 codes on processing the information
Education
Master's degree - E-health and Telemedicine management
Rome business school
01.2021 - 01.2022
Master of clinical Pharmacy - undefined
Dubai Pharmacy College
01.2017 - 01.2021
Diploma - Logistics Supply Chain & Warehouse Management Professional
A.I.B. College of Business
Bachelor's in Pharmacy - undefined
Dubai Pharmacy College
01.2009 - 01.2013
Skills
- Regulatory compliance
- Medical device regulations
- Contract review and recommendations
- Pharmacovigilance
- Pharmaceutical quality assurance
- GMP/cGMP principles
- Electronic Common Technical Document (eCTD) submission
- Product recalls handling
- Regulatory requirements
- Records management procedures
- Product life cycle management
Certification
- Certified Professional in Lean Six Sigma, IMC, 10/01/24
- Professional Certificate in Regulatory Affairs GCC, Strategic Axis Training Academy, Dubai, U.A.E., 08/01/24
- Professional Certificate in Regulatory Affairs GCC, PRA Dubai Pharmacy College, Dubai, U.A.E., 02/01/17
- Certified Professional in Health Care Quality (CPHQ), Transformed, 10/01/15
- Licensed pharmacist, Dubai Health Authority, 09/01/15
- GLOBAL PHARMA CO. (L.L.C.), 02/01/13
Languages
English
Fluent
Arabic
Native
Accomplishments
- Product Registrations: Registered 50+ products (medical devices, supplements, cosmetics) across META, ensuring full compliance.
- Audit Success: Passed 45+ quality audits (PV, DHA, JCI, GMP, MOH, ISO) with no major findings.
- Quality and PV Audits: Successfully passed quality and pharmacovigilance audits for projects with BD, Novartis, Takeda, Roche, Sanofi, and AbbVie.
- Regulatory Engagement: Key liaison for UAE MOH, DHA, SFDA, MOH Oman, and Kuwait MOH .
- Accreditation Excellence: Led JCI and GXP protocol development, improving safety and care standards.
Timeline
Group Operation Manager (Regulatory, Quality & Legal) (MENA)
AG Holding Company
08.2023 - 11.2024
Head of Access to Adherence and Homecare (Greater MENA)
Axios International
01.2022 - 08.2023
Master's degree - E-health and Telemedicine management
Rome business school
01.2021 - 01.2022
Operational Cluster Lead and Greater MENA
Axios International
01.2020 - 12.2021
Adherence Projects Manager
Axios International
11.2017 - 12.2019
Medical Director
Life Pharmacy
02.2017 - 09.2017
Master of clinical Pharmacy - undefined
Dubai Pharmacy College
01.2017 - 01.2021
Pharmacist
Super Care Pharmacies
10.2014 - 06.2016
Insurance Medical Call Canter Agent
NEXTCARE TPA
04.2014 - 09.2014
Bachelor's in Pharmacy - undefined
Dubai Pharmacy College
01.2009 - 01.2013
Diploma - Logistics Supply Chain & Warehouse Management Professional
A.I.B. College of Business
- Certified Professional in Lean Six Sigma, IMC, 10/01/24
- Professional Certificate in Regulatory Affairs GCC, Strategic Axis Training Academy, Dubai, U.A.E., 08/01/24
- Professional Certificate in Regulatory Affairs GCC, PRA Dubai Pharmacy College, Dubai, U.A.E., 02/01/17
- Certified Professional in Health Care Quality (CPHQ), Transformed, 10/01/15
- Licensed pharmacist, Dubai Health Authority, 09/01/15
- GLOBAL PHARMA CO. (L.L.C.), 02/01/13
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