Senior Executive Regulatory Affairs

Title: Senior Executive Regulatory Affairs

Location: Petaling Jaya, MY, MY

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 178621

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.
• License application and maintenance.
• Permit application and follow-up. Keep abreast of updated regulations in Malaysia.
• Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and serving 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 is the 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.
• Act 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).
• Good working knowledge, comprehension and applications of local regulations.
• 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

• Minimum Bachelor's Degree in Pharmacy or related fields.