Mona Alhammadi
Dubai
Summary
Seeking a challenging and rewarding role Regulatory Affairs at international Pharmaceutical companies where practical experience, market knowledge and expertise will be utilized to employ strategic initiatives and propel the organization to the top-tier of its industry.
Overview
15
15
years of professional experience
Work History
Regulatory &Scientific Office Manager
Kenvue (was Part Of JNJ Consumer Health )
01.2023 - Current
- Ensuring that the company comply with all relevant laws and regulations related to the production, distribution, and marketing of products or services.
- Enables businesses to operate in compliance with regulations while still providing innovative and effective products and services and continuing to grow and succeed.
- Strengthen the relations with the Health Authorities in the region that I am covering which was GCC countries
Head of Conventional, Biologic & Biosimilar Drugs
Ministry of Health & Prevention
08.2009 - 01.2023
- In-charge of the development of guidelines, processes and requirements in the new registration of pharmaceutical products (Conventional, Biologic & Biosimilar Drugs) in compliance with MOHAP, to authorize their importation into and sale within the UAE
- Accountable for issuing the Emergency Use Authorization for a broad range of Vaccines including Sinopharm, Pfizer, AstraZeneca, Sputnik V, Sputnik Light, Johnson & Johnson's Janssen and Hayat-Vax
- Serving as one of the core members of the Technical Committee by contributing strategic inputs and action plans in the registration and approval of new medicinal/pharmaceutical products
- Paid attention to detail while completing assignments.
- Worked well in a team setting, providing support and guidance.
- Organized and detail-oriented with a strong work ethic.
- Provided professional services and support in a dynamic work environment.
- Skilled at working independently and collaboratively in a team environment.
- Gained strong leadership skills by managing projects from start to finish.
- Self-motivated, with a strong sense of personal responsibility.
- Instrumental in the end-to-end implementation of an online portal for new registration with sound knowledge of its features and services such as application, cancellation and intellectual property.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Acted as a team leader in group projects, delegating tasks and providing feedback.
- Applied effective time management techniques to meet tight deadlines.
- Developed strong communication and organizational skills through working on group projects.
- Demonstrated leadership skills in managing projects from concept to completion.
- Proven ability to develop and implement creative solutions to complex problems.
- Developed and maintained courteous and effective working relationships.
- Learned and adapted quickly to new technology and software applications.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
GMP Inspector
Ministry of Health & Prevention
01.2019 - 01.2023
- Examined products for imperfections and defects.
- Identified repair and upgrade requirements needed to meet safety and quality standards.
- Reduced the frequency of defects by closely monitoring production processes and identifying areas for improvement.
- Assessed safety and compliance concerns through diligent buildings, rooms and equipment inspections.
- Identified potential hazards and recommended corrective actions, ensuring a safer work environment for all employees.
- Mentored junior inspectors, sharing industry expertise to enhance their skills and abilities in performing thorough inspections.
- Enhanced company safety standards by conducting thorough inspections of equipment and facilities.
Registration Officer
Ministry of Health & Prevention
01.2017 - 01.2019
- Selected as the Head and one of the integral members of Gulf Health Council (GHC) committee with a responsibility to develop the central guidelines, processes and procedures for the registration of new medical device across the GCC
- Proactively involved in the development of criteria and requirements applicable to all various facilities and units of manufacturing to ensure all best quality practices and corrective actions are implemented as per Good Manufacturing Practices for Quality Standards
- Extensive experience in serving as an Inspector for local and international manufacturing facilities for medical device across the US and UAE.
PV Officer
Ministry of Health & Prevention
01.2014 - 01.2017
- Conducting safety and post-marketing surveillance to monitor the medicinal products after being approved for sale and seeing in-market use
- Displayed strong expertise in the management of adverse events, review and approval of Pharmacovigilance plan and assurance of compliance as per regulatory standards.
Pharmacist In Charge
Ministry of Health & Prevention
01.2009 - 01.2014
- Highly experienced in managing the overall pharmacy operations, monitoring drug inventory results, ordering medications and supplies for stock replenishments, verifying the deliveries against the purchase orders, and minimizing stock discrepancies.
Education
Bachelor's Degree - Pharmaceutical Science & Industrial Pharmacy
Misr University For Science & Technology
01.2006
Skills
Registration with different Herbal & GSL Products
- Conventional , Biosimilar & Medical Device Registration
- Good Manufacturing Practice (GMP)
- Continuous Process Improvement
- Drug Safety (Pharmacovigilance)
- Problem Solving & Decision Making
- Strategic Alliances & Partnerships
- Strategic Planning & Execution
- Facility Inspection
- Pharmaceutical Operations
- Documentation & Reporting
- Knowledge of Regulatory Affairs
- Team Supervision / Leadership
- Excellent Communication Skills
- Microsoft Word
- Analytical Thinking
Affiliations
- Member on Technical of New Registration of the pharmaceutical Product
- GCC Summit for Medical Device Regulations
- MOHAP Higher PV Committee
- MOHAP Higher Committee of
Languages
English & Arabic
Speaker
Selected as the speaker and presenter on behalf of the Ministry of Health and Prevention in a conference discussing about the “Role of Digitalization during the COVID-19 Pandemic” at Amsterdam, Netherlands
License
UAE Driver's License
Career Growth
Career Growth at the Ministry of Health & Prevention: (2009 - Present)
References
Available Upon Request
Personal Information
Nationality: Emirati (UAE)
Training
- Good Manufacturing Practices (GMP) Compliance Training - Al Mesned Group
- ISO 13485 Training for Medical Device Facility
- Pfizer Registration Regulatory Workshop
- Pharmacovigilance (PV) Workshop - Amgen Pharmaceutical Company
- Herbal Medicine Conference 2019 - Budapest, Hungary
- OIC Conference 2018 - Jakarta, Indonesia
- Drug Counterfeit Conference 2015 - MOHAP
Timeline
Regulatory &Scientific Office Manager
Kenvue (was Part Of JNJ Consumer Health )
01.2023 - Current
GMP Inspector
Ministry of Health & Prevention
01.2019 - 01.2023
Registration Officer
Ministry of Health & Prevention
01.2017 - 01.2019
PV Officer
Ministry of Health & Prevention
01.2014 - 01.2017
Head of Conventional, Biologic & Biosimilar Drugs
Ministry of Health & Prevention
08.2009 - 01.2023
Pharmacist In Charge
Ministry of Health & Prevention
01.2009 - 01.2014
Bachelor's Degree - Pharmaceutical Science & Industrial Pharmacy
Misr University For Science & Technology
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