Regulatory Affairs Specialist at Linrco Egypt

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Job Description

Responsible for preparation of Registration dossiers of all new products and Re-registered products.
Submitting variations of existing products.
Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug Control and Research ).
Follow up submission and any supporting documents along with registration lead time.
Support logistic team with all references, legalized certificates and material needed for regular analysis and release.
Prepare analytical files to be submitted to different authorized labs
Follow up analysis and supply all needed requirements to get release certificates f samples.
Ensures confidentiality in respect of registration files contents.
Completing all registration requirements for all shipments at EDA.
Responsible for obtaining Ministry of Health importation approvals, inspection & release.

Requirements & Qualifications

Bachelor’s degree in Science, pharmacy or vet medicine.
Knowledge of EDA regulatory affairs is a must.
Hands-on experience in medical devices registration is a must
Experience mainly in sterile medical devices regulatory and submissions in CAPA, NODCAR.
Good knowledge of preparation of registration files.
Excellent command of English and Arabic
1-3 years of experience.

TalentIT Analysis

Quick Role Summary

Opportunity as "Regulatory Affairs Specialist" at Linrco Egypt located in الجيزة on a Full-Time basis, suited for Mid-Senior Level candidates. Key details from listing: • Responsible for preparation of Registration dossiers of all new products and Re-registered products. • Submitting variations of existing products. •…

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