Abouelala El Idrissi - Regulatory Affairs - Casablanca, Grand Casablanca, Morocco

Mohamed Abouelala El Idrissi

Casablanca, Grand Casablanca, Morocco


Regulatory Affairs


Preparation and Submission of Drug Registration, renewals, variation

Work History

RA Coordinator


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

"Novo Nordisk"

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
-Handling Non-Conformities
-Calibration of the fridges/Iceboxes of the Field Force.
-Business Ethics.
-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.


QA Department

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.


Analytical laboratory

December 2010 - February 2011


Qualifications & Certifications

University of Medicine & Pharmacy of Rabat

Biological sciences

University of Science HASSAN II Casablanca

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