Hatem Khalifa
Senior Regulatory Affairs (cosmetics , food , pharmaceutical) and Quality (ISO 22000 Auditor)
Cairo
Summary
Senior Regulatory Affairs Officer with [10] years in developing effective processes and executing regulatory affairs initiatives for [cosmetics and food and beverage ] industry. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Dedicated cosmetics and food and beverage professional with history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Expert in handling international brands with all complaisance and regulations needed
Overview
25
25
years of professional experience
5
5
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs Manager and Lead Auditor
Trade Art for import and consultation
cairo
01.2016 - Current
- Performed and documented quality control checks to maintain compliance with company initiatives.
- handling international brands regulation and compliance
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Provided responses to regulatory agencies regarding product information or issues.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- such ( emami limited cosmetics , rasasi LLC , swiss arabian , romaron , martin lion , DXN cosmetics, food supplements and cosmetics
- Worked with governance committees to make and evaluate plans.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Recommended improvements to processes.
- Assisted with regulatory product compliance initiatives
- Consulted with regulatory representatives to manage filings, applications and reports.
- Trained staff in regulatory policies or procedures.
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
Regulatory Affairs Manager and Lead Auditor
trad art for import and consultation
Cairo, C
01.2016 - Current
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Worked with governance committees to make and evaluate plans.
- Recommended improvements to processes.
- Assisted with regulatory product compliance initiatives
- Led product teams of [5 ] for regulatory product compliance
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and maintained document inventory for core dossier preparation.
- Provided responses to regulatory agencies regarding product information or issues.
- Directed documentation efforts to comply with domestic and international regulations and standards.
- Trained staff in regulatory policies or procedures.
- Managed all regulatory needs for products
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries.
- Consulted with regulatory representatives to manage filings, applications and reports.
- Devised and deployed techniques for obtaining earliest possible approval for each product.
- Performed and documented quality control checks to maintain compliance with company initiatives
- Worked with governance committees to make and evaluate plans
- Prepared and maintained document inventory for core dossier preparation
- Prioritized project-related tasks to efficiently complete essential tasks
- Represented company in [food and cosmetics and pharmaceutical ] industry during communications with global regulatory agencies
- Analyzed field studies and reports, compiled information and submitted concise and informative summaries
- Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries
- Devised and deployed techniques for obtaining earliest possible approval for each product
- Consulted with regulatory representatives to manage filings, applications and reports
- Trained staff in regulatory policies or procedures
- Directed documentation efforts to comply with domestic and international regulations and standards
Regulatory Affairs and Compliance Manager
Alshaya group
cairo
01.2012 - 01.2016
- Prepared and presented comprehensive reports to upper
- handling international brands registration and regulation with MOH , NFSA ,GEOIC ,Custom and all authority's .
- Collaborated with contract team to review client contracts and facilitate personnel compliance training.
- Advised division leaders of regulatory risks in business processed and provided recommendations for improvement.
- Verified consistency in quality planning, quality control, quality insurance and quality improvement.
- Collaborated with HR and IT to develop and implement code of business and ethics and anti-harassment policies and related personnel training.
- (H&M , victoria secret ,bath and body works , the body shop , starbucks
- management and audit team, covering issues and recommendations.
- Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
- Conducted quarterly audits of environmental management compliance.
- Backed data security and information privacy efforts.
- Liaised with clients to identify and target inefficiencies in areas of risks and business controls, process gaps and workflow discrepancies.
- Reviewed documents, files, transcripts and other records to assess compliance and potential risk.
Regulatory Affairs Specialist
alshaya group
kuwait
01.2010 - 01.2012
- Prepared and submitted regulatory file applications and supporting documentation.
- Consolidated global information relevant
- monitored global submissions and approvals status.
- Maintained and archived regulatory paperwork.
- create product technical file packages for global product compliance certifications
- Received, researched and resolved consumer inquiries.
- Assisted with regulatory product compliance initiatives
- Recommended improvements to processes.
- Prepared and maintained document inventory for core dossier preparation.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Worked with governance committees to make and evaluate plans.
Drug Representative
will care pharmacutical distributors
Cairo
01.2008 - 01.2010
- Used Microsoft Word and other software tools to create documents and other communications.
- Handled calls per day to address customer inquiries and concerns.
- Developed team communications and information for meetings.
- Used coordination and planning skills to achieve results according to schedule.
- Improved operations through consistent hard work and dedication.
- sales target of the products
- handling doctor visits
- introducing the product and explaining the drag pharmacological
Pharmacist
ibn sina pharma
Dubai
01.2004 - 01.2007
- Interpreted prescription orders, dispensed medications and counseled patients on drugs.
- Recommended OTC devices or medication options to help mitigate individual symptoms.
- Worked as preceptor to provide practice-based instruction to students at pharmacy practice sites.
- Reviewed and evaluated orders for non-formulary to identify generic alternatives.
Education
Bachelor of Science - Pharmacy
Virgen Milagrosa University
Philippines 01.1996 - 04.2001
Antimicrobial Stewardship Courses - Surveillance Technology To Support Regulatory
Stanford University
USA 07.2022 - 08.2022
Nutrition Science Courses - Nutrition Science Introduction To Food And Health
Stanford University
USA 07.2022 - 08.2022
ISO 22000 Lead Auditor - Lead Auditor For Food Manufacturer Quality (ISO)
IQMS
UK 03.2017 - 03.2017
Skills
Regulatory standards
undefinedWork Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
The way to get started is to quit talking and begin doing.
Walt Disney
Timeline
Antimicrobial Stewardship Courses - Surveillance Technology To Support Regulatory
Stanford University
07.2022 - 08.2022
Nutrition Science Courses - Nutrition Science Introduction To Food And Health
Stanford University
07.2022 - 08.2022
ISO 22000 Lead Auditor - Lead Auditor For Food Manufacturer Quality (ISO)
IQMS
03.2017 - 03.2017
Regulatory Affairs Manager and Lead Auditor
Trade Art for import and consultation
01.2016 - Current
Regulatory Affairs Manager and Lead Auditor
trad art for import and consultation
01.2016 - Current
Regulatory Affairs and Compliance Manager
Alshaya group
01.2012 - 01.2016
Regulatory Affairs Specialist
alshaya group
01.2010 - 01.2012
Drug Representative
will care pharmacutical distributors
01.2008 - 01.2010
Pharmacist
ibn sina pharma
01.2004 - 01.2007
Bachelor of Science - Pharmacy
Virgen Milagrosa University
01.1996 - 04.2001
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