Regional Submission Planner

Hirdetés feladója: Career Oppurtinities
Munkavégzés helye: Budapest XI. kerület (Pest megye)
Jelentkezési határidő: 2021. augusztus 23.
Várható kezdés: 2021. augusztus 24.

Elvárások a jelölttel szemben

  • Bachelor’s degree in a Life Science related discipline.
  • High-level expertise and knowledge of the regulatory landscape, its registration procedures, and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
  • Affinity to work with complex IT systems
  • With at least 2 years of experience in the regulatory operations area, regulatory affairs will be an asset.

Szükséges nyelvismeretek

  • Angol - Középfok, szóban és írásban


  • Support the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.
  • Review and manage the complexity of planning, managing, tracking, assembling, and delivering regulatory content, meeting regulatory strategy, regulatory compliance, and informational needs of regional regulatory authority.
  • Help with project management tasks, including managing dynamic timelines, interacting and negotiating, and collaborating with global stakeholders 

Your main functions would be:

  • Managing operational aspects of submission planning for assigned products
  • submission planning
  • document retrieval
  • submission creation and delivery to Health Authorities

Jelentkezés módja / egyéb közlendők