Dalya Ahmed Raafat

Export Regulatory Unit Head at Sedico

6th of October, Giza, Egypt

Mohammed Alkhuraiji Industrial Company

Jan 2023 - Apr 2025 -2 yrs, 3 months

Saudi Arabia , Riyadh

Middle East Pharmaceutical industries (Avalon Pharma)

Dec 2017 - Dec 2022 -5 yrs

Saudi Arabia , Riyadh

Job Details:• Preparing and reviewing regulatory Submissions for Domestic and international projects in Middle East, GCC, Africa and CIS Countries. • Communicating with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements and clarifications, and follow-up of submissions under review. • Reviewing product promotional materials, labels, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. • Preparing and maintaining technical files as necessary to obtain and sustain product approval. • Providing Pre-, Ongoing and Post Inspection follow-up assistance to governmental inspectors. • Writing and updating standard operation procedures (SOP), work instructions and policies. • Compiling and maintaining regulatory documentation database and systems. • Recommending adjudications for product complaints. • Member of Export Committee for Registration, Labeling information and Formulations. • Developing and conducting employee regulatory training.

Middle East Pharmaceutical Co (Avalon Pharma)

Dec 2017 - Dec 2022 -5 yrs

Saudi Arabia , Riyadh

Job Details: Leading Regulatory A airs Team for Preparing and reviewing regulatory Submissions for Products Registration (New and Maintaining) in Body Authorities of Gulf, Africa and Levant (Saudi FDA, GHC, UAE MOHP, Dubai Municipality, Bahrain NHRA, Kuwait MOH, Oman MOH, Yemen MOH, Jordan FDA, Iraq MOH, Lebanon MOHP, Uganda FDA).  Communicating with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarifications, and follow-up of submissions under review.  Reviewing product promotional materials, labels, batch records, specification sheets, and test methods for compliance with applicable regulations and policies.  Compiling and maintaining regulatory documentation database and systems.  Recommending adjudications for product complaints.  Member of Export Committee for Registration, Labeling information, and Formulations.  Developing and conducting employee regulatory trainIng.

Export Regulatory Unit HeadFull Time
Jan 2011 - Present -14 yrs, 6 months
Egypt , Giza
- Job Details:Over 12 Experience in the field of Regulatory Affairs responsible Preparing Products Registration Files for Local Registration in Egyptian MOH , In addition to Preparing Registration file for Export for Other countries in Africa , CIS Countries, Gulf Region and Far East (According to implemented Registration Guidelines whether Regular, Nees, CTD and eCTD Format). 2 Years Experience as Export Regulatory Coordinator responsible for Coordination between Different Departments of Company , to get tasks done, Communication with Agents regarding Registration issues, and following up till registration process is done and Registration Certificate is gained.
Regulatory Affairs OfficerFull Time
Dec 2002 - Dec 2010 -8 yrs
Egypt , Giza
- Job Details:• Communicated regulatory information to multiple departments and ensured that information was interpreted correctly. • Participated in preparation and submission of regulatory agency applications, reports, or correspondence.

Pharmaceutical Science in Pharmaceutical Science
Zagazig University (ZU)
Jan 1998 - Jan 2002 - 4 yr