Labeling Compliance Specialist

hace 5 días


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

Job Summary

The Regulatory Affairs Specialist will work closely with the RA Lead, RA Labeling Lead, and GLLs (Global Labelling Leads) to ensure the success of various projects and initiatives.

This role involves managing the Regulatory Information System, updating submission due dates, and assisting with CCDS template/content transfers.

The specialist will also be responsible for managing the Takeda Global Labeling (GL) mailbox and operating in line with QMS documents and non-QMS documents for regulatory services provided.

Key Responsibilities

  1. Ensure RIM systems are up-to-date with regard to labeling CCDS events.
  2. Distribute CCDS to relevant stakeholders.
  3. Update the Regulatory Information System to capture submission due dates and deferred submission dates.
  4. Support the GLL with CCDS template/content transfers and SRQC.
  5. Assist the Labeling Lead and Global Labeling Leads with administrative tasks.

Qualifications

To be successful in this role, you should have a Bachelor's Degree in Health Sciences or a related field, along with 1-3 years of experience in US labeling activities or 2-4 years of experience in local labeling activities.

You should also possess advanced English skills, including writing and speaking, and be proactive, attentive to details, and willing to learn and be autonomous.



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