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Regulatory Submission Associate


Job description:

The role compiles, reviews, and publishes submissions in eCTD format:

  • Use the electronic publishing software according to the system User Guide and internal procedures.
  • Work closely with local and corporate Regulatory Affairs to support the preparation of eCTD submissions.
  • Compile and publish submissions in eCTD format for NP products according to EU requirements on eCTD format and internal procedures.
  • Review submissions in eCTD format for DCP/MRP products according to EU requirements on eCTD format and internal procedures.
  • Import to the electronic publishing software eCTD applications that have been published in different systems.
  • Maintain an archive of approvals received from regulatory agencies.
  • Prepare and maintain cumulative approved dossiers in eCTD format.
  • Support the electronic submissions using EU submission portals: CESP, EMA WebClient.
  • Follow up on the assigned tasks and deadlines.
  • Monitor the status of the eCTD applications.
  • Stay up to date with the EU requirements on eCTD format.
  • Report electronic publishing software issues to the Help Desk of the software provider.
  • Maintain regulatory databases and trackers updated.
  • Perform regular corporate trainings requested.


  • University/ college degree in Chemistry, Biology, Pharmacy, Medicine, Life Science.
  • General knowledge of Regulatory Affairs processes.
  • Fluent written and spoken English.
  • Ability to prioritize own workloads to meet deadlines.
  • Result and detail-oriented approach to work delivery and output.
  • Enthusiastic, proactive, self-driven, and willing to take over new responsibilities.
  • Team player and also able to perform alone.
  • Strong communication, interpersonal, and organizational skills.
  • Problem solving skills.
  • Excellent computer skills including MS Office applications.
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