Professional Regulatory Site Officer, Cairo - Sanofi

Job Purpose:

• Co-ordinate between Industrial Affairs department and DRA department in regulatory aspects of chemistry, manufacturing and control for pharmaceutical products.
• Manage the regulatory aspects of the change control requests in accordance with the directive and guideline.
• Manage the regulatory activities with the Ministry of Health Inspection Department.

Responsibilities and Tasks:

1- Preparing the registration files in coordination with DRA department during                 

    new registration or re-registration

• Preparation of IA part of regulatory files (Products Renewal)
• Reviewing of IA part of regulatory files (New Products)
• Regulatory compliance checking (Gap analysis) Re-organization of registration dossiers
• Review & Approval of updated method of analysis from QC 
• Revising stability data, gathering raw material specifications, printed packaging materials.
• Send updated data to DRA with samples of finished products, with their certificates.
• Managing of submission of variations to DRA to be submitted to MOH to close any identified regulatory GAPs found.
• Initiate the eCTD file for local and exported products.

2- Handling of Change control (Follow up of Actions)

• Receive a change control request form any department by Phenix system
• Follow up of evaluation of change control request with Quality Operations head.
• Communicate with the experts in concerned departments to perform the pre-actions plan Communicate CCC if needed for any change with global regulatory impact.
• Follow up the implementation of the action plan with concerned departments by Phenix system
• Evaluation of final report concerning the actions of the change.
• Closing the change control
• Reporting the Change Control status to Quality Operations Head on monthly basis.
• Follow up the implementation of the action plan with concerned departments’ delegates in the Change Control Committee & Follow up Meetings.
• Assessment of DS CCRF received by Cairo Site

3- Assessment of relevant Department GQD and preparation of site documents accordingly

4- Regulatory Compliance Assessment and Maintenance

5- Support (as applicable) in managing regulatory activities with the MOH inspector

a) Receiving of all the new MOH decisions & informing the concerned departments for implementation.

b)  Managing the release of certain products with the MOH inspector.

c) Following Raw materials & finished products sampling with the MOH

     inspector on weekly basis

6- HSE Responsibilities

• Ensures HSE approval on any SOP that requires certain HSE precautions.
• Ensures HSE approval on any change.
• Follow the approved HSE policy and requirements.
• Following the statutory legislation concerning Health, Safety and environmental law.

Key “MUST HAVE” competencies, skills & experiences

• Pharmaceutical education Background.
• 0 to 2 years of experience within Quality , Production or regulatory affairs.
• Profound communication and negotiation skills with internal and/or external customers.
• Problem solving and Decision making capabilities.
• Excellent knowledge of Microsoft office.
• Good command of English.

“Desirable” / compromise  experience

• The flexibility to multitask and handle multiple requests with varying degrees of priority simultaneously.
• CTD writing experience is a plus

Apply Here