Preparation and Submission of Drug Registration, renewals, variation
From March 2013
-Pursue new product registrations and maintain existing portfolio by planning for Renewals' & variations' submissions timely.
-Handling of additional queries from the MoH during the pre-registration & post marketing periods.
-Guarantee good ethics during the interactions with government officials ("ABAC Policy": Anti-Bribery Anti-Corruption policy).
-Management of the Labelling lifecycle process, and ensuring its timely transmission to the site for release of batches.
-Managing change of (Release/End-Life ) specifications related to product: Transmission to the site after regulatory approval.
-Management of the validation circuit related to the Promotional material in collaboration with the Medical & the Marketing.
-Management of legal RCPs validation to be transmitted to the Marketing.
-Management of technical complaints in collaboration with the site.
-Approval process of Technical Terms of Supply in collaboration with the Demand (Logistic Process).
-Management of Pricing Process in collaboration with the Finance & the Marketing.
-Provide advice and guidance to staff in order to keep them informed of the regulatory approval process and status.
RA & QA Officer
September 2011 - March 2013
-Drug Registration/Renewal/Notification/Deregistration Files: Preparation and Submission.
-Translation of Professional leaflets from English Neutral to French & Arabic.
-Handling of RA Additional Requests from the Health Authorities via the local distributor (LAPROPHAN).
-Validation of Promotional material.
-legal RCPs validation.
-Communication with the Head Quarter in Denmark.
-Collaboration with other affiliates of Novo Nordisk in the region (Maghreb, Africa, Golf, et India).
-Monthly reporting to the regional office (Dubaï).
-Handling of the SOPs and Procedures.
-Training of the staff.
-Handling Change Control
-Calibration of the fridges/Iceboxes of the Field Force.
-Handling of Technical complaints.
-Samples Traceability (Physician Requests, Temperature monitoring of the field force ).
-Handling of Temperature deviation during the shipments.
-Audit of the Local Distributor.
-Annual Quality Activity Plan.
-Annual Quality management Review.
March 2011 - June 2011
Acknowledgment of Quality Assurance procedures being applied within the pharmaceutical industry
-Achievement of QA tasks.
-Mission: Collaboration in the establishment of a new computerized system of Quality Management.
December 2010 - February 2011
Qualifications & Certifications
University of Medicine & Pharmacy of Rabat
University of Science HASSAN II Casablanca
Skillpages has been acquired by Bark.com!
Bark.com is pioneering the way people find local services. Skillpages is the world’s premier directory of service providers.Find out more