Nadeen Al Dibsi
Senior Manager Regulatory Affairs - SFDA,GCC & JFDA at AlSafa

Profile

May 1, 2018-up to date- ALSFA Company-Jordan
Position Title: Senior –Manager Regulatory Affairs
*Duties and responsibilities: 1-Reviweng APIs DMF and comparing with Guidelines requirement 2- Ordering the required documents for Registration file 3- Following up with all companies to complete the missing documents 4- Make evaluation for registration files and request the missing document 5- Make renewal of registration for expired product license 6-Make classification for new products 7- Prepare all types of files: CTD, NEES, VNEES & eCTD 8-Prepare the registrations file according to GCC & SFDA Guidelines for Pharmaceutical Products, Health & Herbal products, Veterinary products, Health product subject for Listing 9-Make listing for Cosmetics in SFDA E-Cosma system 10-Make registration for Medical devices in MDMA system 11-Make registration for Food products & Pesticides 12-Make registration for cosmetics in JFDA 13-Preparing response for FDA inquiries 14- Make follow up to complete the FDA inquiries 15- Prepare PIL (Patient Leaflet) , SPC (Summary of Product Characterization) & Packaging Designs According to SFDA & GCC guidelines 16-Working on DATA matrix code bar code requirements

Dec 1, 2015-till 31 Jan. 2019. Al-Ashban Company-Saudi Arabia
Position Title: Regulatory Affairs Consultant (Part time)
Duties and responsibilities: 1-Reviweng APIs DMF and comparing with Guidelines requirement 2- Ordering the required documents for Registration file 3- Following up with all companies to complete the missing documents 4- Make evaluation for registration files and request the missing document 5- Make renewal of registration for expired product license 6- Prepare all types of files: CTD, NEES, VNEES & eCTD 7-Prepare the registrations file according to GCC & SFDA Guidelines for Pharmaceutical Products, Health & Herbal products. 8-Make listing for Cosmetics in SFDA E-Cosma system 9-Preparing response for SFDA inquiries 10- Make follow up to complete the SFDA inquiries 11- Prepare PIL (Patient Leaflet) , SPC (Summary of Product Characterization) & Packaging Designs according to SFDA & GCC guidelines

Jun 1, 2015-till 1 sep. 2017- ALSFA Store Co. LTD. For Medical-SaudiArabia
 Position Title: Regulatory Affairs Supervisor
*Duties and responsibilities: 1-Reviweng APIs DMF and comparing with Guidelines requirement 2- Ordering the required documents for Registration file 3- Following up with all companies to complete the missing documents 4- Make evaluation for registration files and request the missing document 5- Make renewal of registration for expired product license 6-Make classification for new products 7- Prepare all types of files: CTD, NEES, VNEES & eCTD 8-Prepare the registrations file according to GCC & SFDA Guidelines for Pharmaceutical Products, Health & Herbal products, Veterinary products, Health product subject for Listing 9-Make listing for Cosmetics in SFDA E-Cosma system 10-Make registration for Medical devices in MDMA system 11-Make registration for Food products & Pesticides 12-Preparing response for SFDA inquiries 11- Make follow up to complete the SFDA inquiries 13- Prepare PIL (Patient Leaflet) , SPC (Summary of Product Characterization) & Packaging Designs according to SFDA & GCC guidelines 14-Working on DATA matrix code bar code requirements 15-Working on import & Clearance requirements

Sep14,2013-Apr1,2015. Avalon Pharmaceutical company- Saudi Arabia
 Position Title: Regulatory Affairs officer
Duties and responsibilities: 1-Reviweng APIs DMF and comparing with Guidelines requirement 2- Ordering the required documents for Registration file 3- Following up with all departments to complete the missing documents 4- Make evaluation for registration files and request the missing document 5- Make renewal of registration for expired product license 6-Make classification for new products 7- Prepare all types of registrations files: CTD, NEES, Herbal Listing Files & eCTD 8-Prepare the registrations file according to GCC & SFDA Guidelines 9-Prepared 9 files of Herbal products and 56 files for drug products 10- Preparing response for FDA inquiries 11- Make follow up to complete the FDA inquiries