Mai Hussein
Dubai,DU
Summary
Driven by a results-focused approach, I enhanced regulatory compliance and product quality at Gulf Food Industries - California Garden, leveraging skills in regulatory submissions and analytical thinking. My proactive audits and collaboration efforts led to significant improvements in processes and team competency, showcasing my dedication to excellence and attention to detail.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Lead
Gulf Food Industries - California Garden
04.2022 - Current
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Monitored industry trends and regulatory updates, maintaining a strong understanding of current best practices in the field.
- Supported global product registrations by liaising with international partners and assisting with local regulatory requirements.
- Developed training materials for new hires, facilitating knowledge transfer and enhancing overall team competency in regulatory affairs.
- Prepared comprehensive reports on the status of ongoing regulatory projects for management review and decision-making purposes.
- Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
- Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
- Provided guidance to team members on regulatory requirements, promoting a culture of compliance within the organization.
- Played an instrumental role in obtaining approval for multiple products by effectively managing filing timelines and deliverables.
- Maintained and archived regulatory paperwork.
- Prepared and submitted regulatory file applications and supporting documentation.
Regulatory Affairs Sepcialist
Gulf Food Industries - California Garden
01.2015 - 03.2022
- Prepared and submitted regulatory file applications and supporting documentation.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Maintained and archived regulatory paperwork.
- Ensured consistency in product labeling by reviewing and approving label designs and promotional materials.
- Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
- Reviewed advertising materials before release to verify claims were supported by scientific evidence, minimizing potential legal risks.
- Worked with governance committees to make and evaluate plans.
- Led product teams of [Number] for regulatory product compliance on [Product or Service].
- Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
- Advised executive management on the strategic direction of regulatory activities, incorporating both short-term and long-term goals for the company.
- Wrote or updated standard operating procedures, work instructions or policies.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Provided training to colleagues on regulatory requirements, resulting in increased awareness and overall compliance within the organization.
- Assisted in preparation of high-quality submissions for FDA approval, leading to faster market entry for products.
Supplier Quality Specialist
Gulf Food Industries - California Garden
12.2013 - 12.2014
- Reduced non-conformance issues by closely monitoring supplier processes and ensuring adherence to quality standards.
- Improved overall product quality through continuous improvement initiatives with suppliers, focusing on root cause analysis and problem-solving techniques.
- Inspected items and compared against standards to meet regulatory requirements.
- Recorded and organized test data for report generation and analysis.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Collected and analyzed data to measure effectiveness of quality control processes.
- Coordinated regular supplier meetings to review performance metrics and drive continuous improvement efforts across the supply chain.
- Enhanced supplier performance by conducting thorough audits and implementing corrective action plans.
Education
Bachelor of Science - Pharmacy
Misr International University
Egypt06.2006
Skills
- Post-marketing surveillance
- Regulatory Submissions
- Labeling and Packaging
- CAPA Management
- Regulatory Policies
- Audits
- ISO Standards
- International Regulations
- Data Verification
- FDA regulations
- Analytical Thinking
- Problem-Solving
- Teamwork and Collaboration
- Time Management
- Attention to Detail
- Problem-solving abilities
Timeline
Regulatory Affairs Lead
Gulf Food Industries - California Garden
04.2022 - Current
Regulatory Affairs Sepcialist
Gulf Food Industries - California Garden
01.2015 - 03.2022
Supplier Quality Specialist
Gulf Food Industries - California Garden
12.2013 - 12.2014
Bachelor of Science - Pharmacy
Misr International University
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