Documentation Coordinator Budapest

Documentation Coordinator
Budapest
Budapest, Budapest, HU

Ancillary Document Coordinator Role**

• Focused on operational ancillary document planning, request, and tracking activities.

In this role, you will be responsible for the coordination of ancillary documents intended to be submitted for the regulatory affairs portfolio, from standard to complex. This includes applying project management skills and regulatory knowledge to ensure timely and accurate submission delivery aligned to both Sanofi and applicable Health Authority standards.

You will partner closely with vendors to execute the preparation and/or request of ancillary documents according to planning. Additionally, you will interact with German Health Authorities to request certain documents and advise stakeholders on ancillary document regulation and guidance to ensure an appropriate understanding of submission requirements.

As an Ancillary Document Coordinator, you will create and maintain templates for specific ancillary document requests, draft and review CPP forms, and work in coordination with vendors to follow ancillary document requests and shipping.

Key responsibilities include:

• Applying expert understanding on ancillary document request per country.
• Creation and maintenance of templates for specific ancillary document requests (e. g. CPP) for assigned portfolio.
• Drafting and reviewing CPP forms.
• Interacting with German HAs to request CPPs or GMP certificates.
• Working in coordination with vendors to follow ancillary document requests and shipping.
• Maintaining ancillary document tracking tool.
• Uploading ancillary documents in Vault RIM.
• Completing metadata for ancillary documents in Vault RIM.
• Partnering with GRA and Digital functions as SME for current processes/data/technologies.