Dalya Rizk

I am an efficient, result oriented professional who has been consistently praised as adaptable by my co-workers and management. Over the course of my 20-year career, I’ve developed a skill set directly relevant to the Regulatory Affairs role you are hiring for, including regulatory compliance, records management and government policy and regulations. Overall, I have consistently demonstrated communication, technical and organizational abilities i

Preparing and reviewing regulatory Submissions for Domestic and international projects in the Middle East, GCC, Africa, and CIS Countries.

 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.

 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.

BACHELOR OF PHARMACY IN PHARMACEUTICAL SCIENCE

MAY 2002 Ι PHARMACY COLLEGE - ZAGAZIG UNIVERSITY