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Naideen Cassim

Naideen Cassim

Regulatory Affairs Specialist

Pharmaceutical / Bio-tech

Johannesburg South, City of Johannesburg Metropolitan Municipality

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About Naideen Cassim:

Regulatory Affairs Specialist 

Experience

Application for new medicines (biological, complementary andorthordox NCE & Generic) eCTD & eSubmission
Compilation of professional information &
patient informationleaflets
Reviewing of artwork for advertising and marketing in line withlatest legislation
Variations to medicine product dossiers (inspectorate, clinical andquality amendments) in line with latest EMA guidelines
Medical device, GMP & manufacturing licence applications
Compilation and review of SOP’s
Review of Quality Management Systems

Education

University of Witwatersrand Bsc Honours 

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