
Sara Mamdouh Lithy
Change Control & Regulatory Experts
Cairo, EgyptWork Experience
Senior Regulatory Site OfficerFull Time
SANOFI
Jan 2013 - Present -12 yrs, 5 months
Egypt , Cairo
- Job Details: Co-ordination between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing and control for pharmaceutical products including preparation and dispatch of regulatory dossiers (CMC & CTD) Assessment and maintenance of regulatory compliance SMF “Site Master File” maintenance Management of the change control process and electronic system in Cairo site. Management of the regulatory activities with the Ministry of Health Inspection Department.
Regulatory Affairs SpecialistFull Time
EIPICo
Jun 2009 - Dec 2012 -3 yrs, 6 months
Egypt , Cairo
- Job Details:Responsible for Local Registration, International Registration and Patent & Rights of Intellectual Property
Medical RepresentativeFull Time
UGP, United Group Pharmaceuticals
Apr 2009 - May 2009 -1 month
Egypt , Giza
Education
Bachelor's Degree in Pharmacy
Ain Shams University (ASU)Jan 2003 - Jan 2008 - 5 yr
High School - Thanaweya Amma
El Khalifa El MaamounJan 2003
Skills
Languages
Arabic
FluentEnglish
FluentFrench
Beginner
Training & Certifications
How to prepare a CTD file
Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances “AUPAM”·2010Adverse Event Reporting
Pfizer·2010CTD & eCTD Authority Course
Scientific Office for System & Solution Design·2009CTD & eCTD Manager Basic Course
Scientific Office for System & Solution Design·2009Uncover Counterfeit and Promotional Claims
Scientific Office for System & Solution Design”·2009Selecting Unified Product Name
Scientific Office for System & Solution Design·2009Selling Skills
UGP, "United group pharmaceuticals"·2009