Mona Kamal Mahmoud
Sharjah
Summary
Regulatory Affairs & Documentation Specialist with over 15 years of experience supporting legal and regulatory functions in multinational organizations. Skilled in preparing regulatory submissions, managing product documentation, liaising with GCC authorities, and ensuring compliance with regional regulations. Adept at coordinating cross-functional teams to deliver accurate documentation under strict deadlines.
Experienced in managing large client caseloads through diligent planning and project coordination. Investigates with due care and diligence to identify concerns and achieve positive outcomes. Communicates and presents confidently to engage staff, stakeholders and clients in program activity.
Overview
18
18
years of professional experience
2007
2007
years of post-secondary education
1
1
Certification
Work history
Regulatory Affairs Officer
Nazih Trading Co. L.L.C
Sharjah
01.2019 - 09.2025
- Prepared and submitted product documentation in compliance with GCC regulations.
- Liaised with authorities and suppliers to ensure product approvals and certifications.
- Drafted and reviewed labeling, packaging, and product information leaflets.
- Monitored regulatory changes and updated documentation processes accordingly.
- Supported Legal Department in maintaining compliance and regulatory records.
- Implemented new procedures for improved operational efficiency in regulatory affairs department.
- Authored all necessary documentation, ensuring transparency and clarity.
- Stayed abreast of industry trends and legislative changes to maintain competitive edge.
- Collaborated cross-functionally with various departments to ensure alignment in regulatory affairs strategy.
- Prepared comprehensive reports for top-level management.
- Enhanced compliance standards with implementation of rigorous internal audits.
- Updated policies and procedures to reflect changes in regulations.
- Managed workload effectively, meeting strict deadlines consistently.
- Negotiated successfully during inspections conducted by regulatory bodies.
- Maintained detailed records of all correspondence with regulatory bodies, ensuring accuracy at all times.
- Streamlined regulatory approval process by liaising with relevant authorities.
- Responded to compliance-related queries, keeping up to date with changes to regulations.
- Reported on compliance performance to senior management.
Administrative Assistant
Nazih Trading Co. L.L.C
Sharjah
01.2016 - 01.2019
- Assisted with trademark registration, commercial agency renewals, and compliance filings.
- Supported regulatory submissions by maintaining accurate documentation.
- Coordinated insurance renewals and ensured regulatory documentation compliance.
- Managed filing systems to support legal and regulatory functions.
- Submitted timely reports which provided critical updates on various projects.
- Facilitated internal communication.
- Streamlined administrative processes for increased efficiency in workplace.
- Expedited document filing system with new, organized method.
Admin Assistant
The Health Medical Services L.L.C
Al Ain
01.2015 - 12.2015
- Coordinated patient service approvals with Daman Insurance.
- Prepared quotations and maintained compliance documentation.
- Organized department meetings and maintained records for audit purposes.
- Improved customer satisfaction through prompt response to email and phone queries.
- Handled sensitive information discreetly maintaining high level confidentiality at all times.
- Supported accurate record-keeping with proficient data entry skills.
- Examined, scanned and input documents in software system.
Admin Assistant
Arak Consulting Engineering Co.
Al Ain
01.2013 - 12.2014
- Supported engineers with authority-related documentation submissions.
- Drafted official correspondence to regulatory authorities.
- Maintained compliance records and filing systems.
- Contributed to team effort by accomplishing related results as needed.
- Performed bookkeeping tasks, including invoicing and expense tracking.
- Expedited document filing system with new, organized method.
- Updated company databases by inputting new employee contact information and employment details.
Admin Assistant
Egypt Kuwait Holding Co.
Cairo
01.2010 - 12.2013
- Assisted with compliance reporting and board-level documentation.
- Maintained confidential compliance records.
- Coordinated with financial authorities and regulators on company filings.
- Improved customer satisfaction through prompt response to email and phone queries.
- Organised client meetings, prepared agendas and took detailed minutes.
- Facilitated internal communication.
- Handled sensitive information discreetly maintaining high level confidentiality at all times.
- Supported accurate record-keeping with proficient data entry skills.
- Interacted professionally with clients providing excellent service at all times.
Admin / HR Assistant
I Source Company
Cairo
01.2008 - 12.2010
- Supported compliance with labor laws and HR policies.
- Maintained regulatory documentation for employee insurance and contracts.
- Coordinated HR-related documentation audits.
- Managed payroll system to ensure timely and accurate payments.
- Achieved improved relations with staff through regular one-on-one meetings.
- Maintained employee records, ensuring compliance with data protection regulations.
- Enhanced employee engagement by organising team building activities.
- Assisted HR manager in implementing diversity and inclusion initiatives.
- Completed timely reports on HR metrics contributing towards strategic planning.
- Provided support during performance review processes, leading to smoother operations.
- Reviewed job applications to identify, vet and recommend optimal candidates for available positions, maintaining positive relationships with clients.
- Maintained and updated personnel records, storing employee information accurately for traceability compliance.
- Coordinated employee exit interviews and paperwork.
HR Clerk
Alkan Networks
Cairo
01.2008 - 12.2008
- Supported HR documentation compliance processes.
- Prepared reports and maintained accurate employee records.
- Assisted in recruitment and compliance with medical insurance requirements.
- Actively participated in HR project meetings contributing valuable insights.
- Organised company-wide events promoting team building.
- Monitored performance appraisal schedule ensuring timely assessments were conducted.
- Coordinated staff training sessions, enhancing professional development.
- Initiated recognition programmes boosting employee morale.
- Streamlined HR processes for improved efficiency.
Education
Master of Arts - Faculty of Law
Ain Shams University
Cairo07.2007
Skills
- Regulatory Submissions & Documentation
- Compliance Monitoring & Reporting
- Product label & Packaging Compliance
- Trademark & Legal Certifications
- Records & File Management
- MS Office Suite (Word, Excel, PowerPoint)
- Variation and Submission experience
- Product lifecycle knowledge
- Product registration procedures
- Medical device regulations familiarity
- Innovation and creativity
- FDA regulation comprehension
- Regulatory documentation writing
- Knowledge of legal obligations
- Regulatory submission processes
- Regulatory compliance
- Regulatory and ethics submissions
- Product registrations
- Process efficiency improvement
- Compliance reporting
- Knowledge of ISO standards
- Project management experience
- Staff training
- Risk Management
- Regulatory audit methods
Certification
- Practical Human Resources Diploma, Cairo, 01/01/09 - 12/31/16
- Basic Business Skills Acquisition, Future Generation Foundation, 01/01/07
- Communication & Human Relations Skills, Dale Carnegie Training, 01/01/07
Languages
Arabic
Native
English
Advanced
Timeline
Regulatory Affairs Officer
Nazih Trading Co. L.L.C
01.2019 - 09.2025
Administrative Assistant
Nazih Trading Co. L.L.C
01.2016 - 01.2019
Admin Assistant
The Health Medical Services L.L.C
01.2015 - 12.2015
Admin Assistant
Arak Consulting Engineering Co.
01.2013 - 12.2014
Admin Assistant
Egypt Kuwait Holding Co.
01.2010 - 12.2013
Admin / HR Assistant
I Source Company
01.2008 - 12.2010
HR Clerk
Alkan Networks
01.2008 - 12.2008
Master of Arts - Faculty of Law
Ain Shams University
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