Regulatory Coordinator - Importation

Job description

Job Purpose:

·  Responsible to know, adhere to and advise others on regulatory authority regulation updates for the related scope.
·  Secure the HAs approvals for customs release purpose of finished goods shipments for imported products by Franco Egypt.
·  Secure the HAs approvals for customs release purpose of regulatory reagents & reference standards shipments imported by Franco Egypt/Sanofi Egypt.
·  Fullfil GRA requests for regulatory documents issuance for exportation purposes (CPP, GMPs, ..etc).
·  Ensure good tracking and archive of all the processes in scope.

Job Responsibilities:

Management of HAs approvals for customs clearance of imported finished goods:

·  Preparation of all necessary documents for submission to HAs per shipment as below:
·  Internally: Medical Stamp fees file for payment issuance
·  Externally (to the HAs):
·  Medical stamp fees dossier
·  Customs release HAs dossier
·  Online submission of the HAs approval requests & fulfill the complementary elements (if any).
·  Follow-up the submission & approval process.
·  Ensure the delivery of the approvals to the Supply Chain team.
·  Ensure the Medical stamp fees settlement with P2P (in case of Cheques payment).
·  Ensure good tracking & archiving of the relevant documentation.
·  Track the imported Quantities versus the approved Qty in the annual importation plan regularly & alert the stakeholders when the remaining Quantity started to be lower than 50%.

Management of HAs approvals for customs clearance of Regulatory reagents & reference standards as needed.

·  Preparation of all necessary documents for submission to HAs per shipment.
·  Online submission of the HAs approval requests & fulfill the complementary elements (if any).
·  Follow-up the submission & approval process.
·  Ensure the delivery of the approvals to the requestor.
·  Ensure good tracking & archiving of the relevant documentation.

Exportation documents (CPPs, GMPs) as requested by GRA for the countries having their product registered from Cairo site.

Supporting license out activities (labelling, ..etc)

Database: Developing and maintaining an accurate and up-to-date database for customs release related activities and deducting the quantities of shipments at the time of goods arrival from the approved quantities as per the annual importation plan.

Others:

·  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.

JOB-HOLDER’s REQUIREMENTS "Must have" :

·  Relevant Bachelor degree preferable Medical Background
·  Relevant experience: Up to 2 years of Relative experience

Special Knowledge/Skills:

·  Computer Skills,
·  Good Negotiation & Communication Skills.
·  Good planning and organization skills
·  Good  Command of English Language

LEAD competencies:

·  Act for Change, Strive for results, Cooperate Transversally, Commit to Customer

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.