Regulatory Site Officer at Sanofi
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
- Pharmaceutical education Background
- 2 to 4 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
Tips for updating your Resume:
- Seniority Junior (1 to 3 years)
- Employer type Multinational Company
Login To Apply For This Job.
January 25 @ 3:00 pm - March 8 @ 8:00 pm EET
February 1 @ 5:00 pm - February 3 @ 10:00 pm EET
February 8 @ 5:00 pm - February 13 @ 10:00 pm EET
February 8 @ 8:30 pm - 9:30 pm EET
March 1 - March 2