Executive Regulatory Affairs

3 weeks ago


Petaling Jaya, Malaysia DKSH Full time

**Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:155287**Description**:
**Job Summary**
- Assist Senior Pharmacist, Regulatory Affairs to cover regulatory affairs matters of DKSH Malaysia Sdn Bhd, Business Unit Healthcare

**General Responsibilities**
- Assist in timely product registration and variation submission via NPRA Quest system for pharmaceutical products. As well as product registration maintenance and document retention.
- Assist in timely product notification submission via NPRA Quest system for cosmetic products, product notification maintenance and document retention.
- 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 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.
- As Document Controller for RA team.

**Functional Skills and Knowledge**
- Demonstrate knowledge in quality assurance tools, concepts and methodologies
- Good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
- Basic understanding of the Global Harmonized System (GHS)
- Demonstrate proficiencies in office productivity tools (e.g. Excel, Word and PowerPoint)
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Demonstrate fluency in local language and ideally in English, both written and spoken

**Education**
- Degree in Pharmacy or related discipline with 2-4 years relevant work experience.

**Why It’s Great to Work at DKSH**

At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services, we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference



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