Found Description
JOB DESCRIPTION
The IDM RIO Execution Hub Associate/Sr Associate provides regulatory support to International country and/or cluster Regulatory teams, managing multi‑regional, regional and national regulatory dossiers across the product lifecycle—from initial registration applications to product withdrawal.
RESPONSIBILITIES
- Identify regulatory requirements for in‑scope submission categories.
- Author, coordinate and deliver local, submission‑ready documents (M1 dossier components, cover letters, variations, MA applications).
- Review and approve the quality of dossier builds, including the table of contents, provided by Hub Submission/Dossier Managers.
- Support general cross‑functional activities such as tenders, out‑of‑stock reporting, annual product quality review, risk minimization plans, and regulatory input for launch planning.
- Respond to health authority queries, including simple HA request responses and c...
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