About this role

  • Posted on

  • Location

    Greece

  • Salary

    Up to €0.00 per hour

  • Type

    Contract

  • Division

    regulatory-affairs-jobs

  • Reference

    BBBH22725_1638378180

  • Start date

    asap

  • Managing this role

Consultant

Ella Cooper

07891025734

154-158 Shoreditch High Street

Description

This is a fully remote position anywhere in Greece requiring expertise in local Greek Regulatory affairs submissions for post authorized products.

Responsibilities:

  • Advice on Greek-specific requirements to support the client in Greece.
  • Support of local Regulatory Submissions
  • Review submission documents against national guidelines including regulatory acceptability and format QC review of submission package documentation
  • Review Labelling and Artwork
  • Review of the final published submission package
  • Notifying team of requests for information from Health Authority
  • Preparation of ready to file RTQ document in accordance with local regulatory standards
  • Provision of strategic advice regarding local regulatory requirements to an internal or external stakeholder.
  • Impact assessments of change control or CCDS changes on locally registered documents.
  • Provide updates to section 1 of country-specific appendices for PBRER’s when required.
  • Consultants should adhere to the new processes
  • (e.g., QC process of Module 1, Artwork QC check) established from time to time.
  • The consultant should perform a complete review of the artworks in contrast to the changed text section.

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