CHC Importation and Release Specialist

Job Description

CHC Importation and Release Specialist page is loadedCHC Importation and Release SpecialistCHC Importation and Release SpecialistlocationsCairo time typeFull time posted onPosted Today job requisition idR2653869Job title:CHC Importation and Release SpecialistAbout the jobCHC 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 releasesMain 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 MaintainAbout youEducation Level:Bachelor of Pharmaceutical SciencesExperience:minimum 2-4 years in any regulatory activitiesSpecific skills, Knowledge and/or Competencies:?Computer Skills, Negotiation & Communication Skills. ?Good planning and organization skills ?Good Command of English LanguagePTW 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. Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn?t happen without people ? people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let?s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our and check out our Diversity Equity and Inclusion actions at ! At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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