Dalya Rizk

Adaptable professional with 20 years of Work Experience and a proven knowledge of Drug Regulatory Body Authorities Regulations in Middle East, GCC, Africa and CIS Countries, with huge record of Successful Regulatory Submissions of Biosimilars, Pharmaceuticals, Medical Devices, Cosmetics, Health, and Food Supplements. Aiming to leverage my abilities to successful fill Relevant Regulatory Affairs Role at reputable pharmaceuticals company

REGULATORY AFFAIRS SUPERVISOR

Dec 2017 - Present

MIDDLE EAST PHARMACEUTICAL INDUSTRIES (AVALON PHARMA) – RIYADH – SAUDI ARABIA

 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