Regulatory Submission Manager - Mississauga

Only for registered members Mississauga, Canada

2 weeks ago

Default job background
198 000 zł - 330 000 zł (PLN)

Job summary

The job holder is responsible for managing end-to-end regulatory lifecycle submissions across multiple markets ensuring timely delivery and compliance with regulatory authority requirements guidance and GSK processes including written standards.

Responsibilities

  • Own end‑to‑end delivery of assigned complex lifecycle regulatory submissions e.g variations PBRERs renewals site registrations/renewals tenders etc ensuring they meet agency requirements agreed dossier strategies timelines while proactively managing risks remediation.
  • Provide peer review quality assurance deliverables support authors on complex non‑routine assignments.
  • Lead drafting authoring technical review of complex multi‑market dossiers deliver high‑quality compliant submissions adhere GSK standards regulatory guidance.

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