Regulatory Affairs Specialist KSA

Description

The Regulatory Affairs (RA) Specialist will fulfill the local regulatory activities to maintain & keep the RA portfolio compliant for KSA (70 %) and UAE (30%) .

You will support RA Manager on operational RA submissions and assist in ensuring continuous compliance with all RA and Safety Officer responsibilities, maintaining readiness for audits and inspections by Healthcare Authorities at all times

You will ensure business continuity by serving as a backup for the RA Manager, as well as for Quality Assurance (QA) and Pharmacovigilance (PV) functions. As Regulatory Affairs, Quality Assurance, and Pharmacovigilance are mandatory functions that must be continuously available on site—including during vacation periods—you will help ensure that at least one qualified RA/QA/PV representative is present on site at all times.

You will provide strategic and operational Regulatory Affairs support for Saudi Arabia to ensure the timely renewal, ...