Regulatory Compliance Expert

2 dni temu


Warszawa, Mazovia, Polska TN Poland Pełny etat
Job Overview

We are seeking a highly skilled Regulatory Specialist to support our operational activities related to the maintenance of marketing authorisations across assigned markets and/or submission types in European Partnership Markets.

This role will involve working closely with country leads, global regulatory teams/centers, and local 3rd party service providers to ensure compliance with regulatory requirements.

The ideal candidate will have a strong understanding of regulatory processes related to license maintenance and experience working in a matrix organization or international environment.

A minimum of 2 years of relevant experience in regulatory affairs and pharmaceutical industry is required.

  1. Supporting country leads in activities related to maintenance of marketing authorizations (MAs) for assigned markets and/or submission types across pharma and vaccines portfolio.
  2. Providing inputs and support to planning and tracking of regulatory activities for defined markets/submission types.
  3. Managing routine operational steps within Regulatory Information Management (RIM) systems related to the local activities within end-to-end regulatory processes, including data assessments.
Required Skills and Qualifications
  • Master's/Bachelor's degree in scientific discipline (life sciences/pharmacy/professions aligned to medicine).
  • Approximately 2 years of relevant experience in regulatory affairs and pharmaceutical industry.
  • Understanding of the pharmaceutical industry and regulatory processes related to license maintenance.
  • Awareness of policies and regulatory climate in Europe.


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