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Global Labeling Operations Coordinator

hace 1 semana

Buenos Aires, Buenos Aires C.F., Argentina IQVIA Argentina A tiempo completo

Role Summary

This Regulatory Affairs Specialist position requires providing support for activities conducted by the RA Lead, RA Labeling Lead, and Global Labelling Leads. The ideal candidate will have experience in US labeling activities or local (own country or LATAM) labeling activities.

Main Responsibilities

  1. Accurately distributes CCDS to relevant stakeholders.
  2. Updates the Regulatory Information System to capture submission due dates, deferred submission dates, and CCDS events on hold due to pending basis label approvals.
  3. Supports the GLL with CCDS template/content transfers and Submission Ready Quality Check (SRQC).
  4. Assists the Labeling Lead and Global Labeling Leads with administrative tasks.
  5. Manages the Takeda Global Labeling (GL) mailbox in line with GL mailbox Job Aid.
  6. Manages labeling folders on Share Point and Electronic Content Management (ECM).
  7. Operates within QMS documents and non-QMS documents for regulatory services provided.
  8. Enters labeling-related tasks in the IQVIA internal Project Management tool.
  9. Reviews open deliverables on a weekly basis and updates as applicable.

Skills and Qualifications

  1. Bachelor's Degree in Health Sciences or related field.
  2. Experience in US labeling activities: requirements, submissions, legislation, compliance. OR experience in local (own country or LATAM) labeling activities.
  3. Advanced English: writing and speaking.
  4. Proactive, attentive to details, good command of communication, willing to learn things and be autonomous.