CHC Importation and Release Specialist

Job title : CHC Importation and Release Specialist
About the job
CHC portfolio
* Secure submission and approval of medical Custom release documents.
• Secure Importation annual plans for imported SKUs
• Secure Importation Approvals per shipment
• Secure imported reference standards, reagents and Regulatory samples
required approvals.
• Importer Register Management process
• Secure HAs inspection visits and batch release approval
• Submission for Samples Analysis
• Medical samples Inspection and release
• Promotional materials inspection and releases
Main responsibilities:
* Interface with various project/product teams
* Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
* Support RA teams' submission and approval follow up.
* Liaise with National organization of analysis and other entities on MAT preparation according to their requirement
* Liaise with Egyptian HA contact person, organizing and preparing HA meeting and attending as appropriate.
* Preparation of Toll card, scientific office and importer creation -Egypt
* Accountable for keeping the databases updated on a timely basis for portfolio he/she supervise.
* Alert Key stakeholders of any delays / risks on file preparation
* Provide support and communicating information on products to other functions (submissions, approvals, etc.).
* Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
* Plan for preparation / review of a release application submission corresponding to company plan as well as the HA guidelines for submission.
* Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
* Updating the internal Sanofi Systems regularly
* Revision and approval packaging material updates on VISTA
* Assure compliance with global IA files
* Following and complying with all the defined internal policies and procedures of working
* Following strictly all the Authority Regulations, decisions & decrees
* Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
* Maintain inspection and release Tracker & tool to keep the stakeholders informed of preparation
* Perform other duties as assigned.
* Respect of company's values, code of ethics and social charter.
* Respect of personal data protection charter.
* Responsible for applying the HSE related requirements for the company in all related working procedures &data of Confidentiality Strict Maintain
About you
Education Level:
Bachelor of Pharmaceutical Sciences
Experience:
minimum ‎2-‎4 years in any regulatory activities
Specific skills, Knowledge and/or Competencies:
•Computer Skills, Negotiation & Communication Skills.
•Good planning and organization skills
•Good Command of English Language

PTW Behaviors:
* Stretch to go beyond the level we have operated at up until now.
* Take action instead of waiting to be told what to do.
* Act in the interest of our patients and customers.
* Put the interests of the organization ahead of my own or those of our team.
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our people, their backgrounds and experiences and provide equal opportunity
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