Regulatory Affairs Coordinator

hace 7 días


Xico, México Worldwide Clinical Trials, Llc A tiempo completo
Job Summary

We are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Worldwide Clinical Trials, LLC. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the smooth operation of our regulatory processes.

Key Responsibilities
  • Coordinate and manage the compilation of regulatory submissions, including protocols, synopsis, ICFs, and labels, for various regions, including EU, CIS, Asia Pacific, and Latin America.
  • Assist with the coordination of translation of regulatory correspondence and submission documents.
  • Pack and dispatch regulatory submissions, site contracts, and site documents, and follow up for delivery confirmation.
  • Perform administrative QC of regulatory submissions, site documents, and site contracts to ensure correct completeness and formatting.
  • Liaise with Finance to request fee payments to Regulatory Authorities.
  • Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action.
  • Contribute to the development and maintenance of Country Intelligence Pages.
  • Coordinate contract signatures by Worldwide authorized personnel, where applicable.
  • Ensure department-specific study files are submitted to Central Records and are consistently audit-ready.
  • Manage tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor.
  • Prepare and submit hardcopies or electronic copies of site essential documents for storage at Central Records.
  • Support Business Development activities by archiving emails and assisting with the generation of slides.
  • Provide relevant administrative training and support to junior staff.
  • Manage third-party vendors, such as printing, courier, and translation service providers.
  • Provide general administrative assistance for the smooth running of the department, including organizing meetings and recording minutes, managing diaries, and assisting with process improvement initiatives.
  • May administratively support therapeutic area-specific training activities in coordination with the SAR department Training Lead, if needed, or for professional self-development, if desired.
Requirements
  • 2 years of office/business experience in a supporting role.
  • Preferable CRO/pharmaceutical industry experience.
  • Bachelor's degree or equivalent preferred.


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