Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

JOB PURPOSE:

• Managing the release process for vaccines and biological imported products portfolio to ensure release activities are done at optimum time thus maintaining products supply versus the required demands.

• Managing the analysis process for vaccines and biological imported products portfolio at the Health Authority labs and securing relevant reagents and reference standards.

JOB RESPONSIBILTITIES:

• Preparation of EDA Inspection visits for vaccines and biological imported products portfolio release including inspection dossiers preparation, NORCB dossiers preparation, reagents, reference standards management and related logistics. 

• Preparation & Submission for NORCB pre-evaluation for biological products and vaccines and follow up with the HAs until the issuance of the Pre-evaluation report. 

• Handle EDA inspection visits and analysis process at NORCB, ….etc. 

• Submission of samples for analysis & regular follow-up until the issuance of the conformity report & final release. 

• Tracking of the required documents supporting the release activities e.g CPPs and GMPs. 

• Archiving of all submission packages, HAs reports and communications. 

• Responsible to know, adhere to and advise others on regulatory authority regulations and guidance to assure smooth releases and comply with all guidelines and new decrees. 

• Ensuring compliance of the release activities with all applicable laws, regulations, and company procedures. 

• Plan and manage the process for reagents, reference standards & any other analysis requirements needed for biological and vaccines batch release including timely orders, follow up until delivery & submission to the HAs. 

• Accountable for maintaining an accurate and up-to-date database in-terms of tracking. 

• Accountable for archiving of all documents related to all activities in scope activities. 

• Support the regulatory team for samples withdrawal for regulatory activities (New registrations, renewals, Variations) upon needed. 

• Adherence to HSE guidelines and compliance rules and regulation. 

• Responsible for the importation process of Sanofi imported portfolio in regard to EDA regulation process.

• Act as the focal point for the post marketing surveillance program for Sanofi’s imported portfolio at the EDA.

JOB-HOLDER ENTRY REQUIREMENTS:

• Education: Bachelor of Pharmaceutical Sciences or other Medical Degree

• Related Experience: Experience of 2-4 years

• Good Command of English Language

• Computer Skills

• Negotiation & Communication Skills.

• Good planning and organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential challenges and opportunities

• Ability to interact and communicate effectively and efficiently with other functional departments in the business and with Health Authorities

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch ‘One day at Sanofi’ and check out our Diversity Equity and Inclusion initiatives at sanofi.com!

null

Strebe nach Fortschritt. Entdecke Einzigartiges.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.