Magda Zedan

Regulatory affairs management experience

Outstanding regulatory affairs management experience for 11 years

Extensive Pharmaceuticals Production experience for 8 years extensive supply chain management for APIs and Raw materials for 7 years .

Remarkable strong & active relations with the regulatory authorties

Successful track of registering new products, renewals of existing products, vatiation, and pricing

Diverse experience across cosmetics, pharmaceuticals, food supplements & medical devices

Excellent communication and negotiation skills

Professional Experience

MultiPharma, Egypt

Regulatory Affairs Manager (2009-Aug., 2021)

Handling and follow up the registration process in all regulatory authorties for cosmetics, pharmaceuticals, food supplements and Medical device.

• Prepare the regulatory documents needed to attain the approval of regulatory agencies needed for the registration.
• Acting as the liaison between the company and the regulatory authorities
• preparation products labels and leaflets in compliance with regulations and specifications
• Resolve any issues related to new product licenses, renewals and variations
• Handling regulatory inspections

MultiPharma, Egypt

Supply chain Manager for APIs & Raw materials (2009 – Aug., 2021)

• Sourcing for New APIs and Raw materials.

-communicating with the suppliers outside Egypt ant all agents in Egypt.

• importing all Raw materials required for production
• dealing with ministry of health and doing the necessary importing approvals for all Raw materials and the final release.

Bioxell Pharma, Egypt

Production and Raw materials supply Manager (2008)

• Purchasing of all API, Raw Materials & Packaging Materials required for company's products
• Management of all production operations & team.
• Purchasing of all API, Raw Materials & Packaging Materials required
• Supply chain management

Multipharma, Egypt

Regulatory affair specialist and raw material supply specialist (2004 - 2007)

• Regulatory affair specialist "handling and follow up the registration process in M.O.H". For cosmetics, pharmaceuticals, medical device & food supplements in all stages of registration. (File documents preparation and following up process in M.O.H.)
• Purchasing of all API, Raw Materials & Packaging Materials required
• Follow up analysis process for each raw materials and the finished products in M.O.H

Production Specialist (1998 - 2003)

Production of tablets, hard & soft gelatin capsules, creams, syrups

Manage all process of dispatching, preparation, filling, compression & packaging till finished product

Professional Development

BIMAG SOLUTIONS MIDDLE EAST S.A.E. (BSME

CTD course, 2012

Zagazig University, Egypt

Clinical Biochemistry Diploma, 2006

A R Design Office, Egypt

Material Requirement Planning, 2003

British council, Egypt

English Conversation Course, 2002

Cairo University, Egypt

BSc. of Chemical Science, 1997