Executive, Regulatory Affairs

Title : Executive, Regulatory Affairs

Location :

Petaling Jaya, MY, MY

Global Business Unit : HEC

Job Function : Regulatory Services

Requisition Number : Description

Job Summary

Assist Regulatory Affairs Pharmacist to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare.

Regulatory Affairs

• Assist in timely variation submission via NPRA Quest system for pharmaceutical products. As well as product registration maintenance and document retention.
• Keep abreast of updated regulations in Malaysia
• Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and serve as the official and full time liaison personnel with the government's regulatory agencies and Ministry of Health.
• Ensure proper documentation of all regulatory applications and communications with clients & Regulatory Authorities
• Ensure DKSH (M) operations are in compliance with all applicable government laws and regulations.
• Ensure services provided are as agreed in RA agreement with Clients.
• Review promotional material, where DKSH as license holder, to ensure contents are fully supported by the Product Information and literature, and in accordance with the PhAMA Code of Conduct and authority's guideline.

General Responsibilities

Pharmacovigilance (PV)

Acts as local Pharmacovigilance associate supporting Primary Pharmacovigilance responsible person (RPPV).

Registered Pharmacist

Functional Skills And Knowledge

Education

Requisition Number : Description