Executive Regulatory Affairs

DKSH Group; Petaling Jaya; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading healthcare service provider in Petaling Jaya is seeking an Executive in Regulatory Affairs. The role involves assisting in regulatory submissions, ensuring compliance with Malaysian regulations, and liaising with local authorities. Candidates must have a Bachelor's Degree in Pharmacy and proficiency in quality assurance tools. The position offers opportunities to engage with clients and support pharmacovigilance activities, ensuring timely reporting and maintenance of necessary licenses.

Qualifications

• Bachelor's Degree in Pharmacy is required.
• Knowledge of Global Harmonized System (GHS) is an advantage.
• Ability to liaise with local Regulatory Authorities.

Responsibilities

• Assist in timely variation submission via NPRA Quest system.
• Ensure compliance with government regulations.
• Conduct pharmacovigilance activities and report Adverse Drug Events.
• Supervise discharge of psychotropic drugs and maintain licenses.

Skills

Knowledge of quality assurance tools

Understanding of Dangerous Goods Regulations

Proficient in office productivity tools (Excel, Word, PowerPoint)

Fluency in local language and English

Education

Bachelor's Degree in Pharmacy

Job description

Executive Regulatory Affairs

Location: Petaling Jaya, MY, MY

Global Business Unit: HEC

Job Function: Regulatory Services

Requisition Number: 219489

Job Summary

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

General Responsibilities

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.

Pharmacovigilance (PV)

• Acts as local Pharmacovigilance associate supporting Primary Pharmacovigilance responsible person (RPPV).
• Liaises with Client PV contact persons for timely reporting of Adverse Drug Events and submitting these reports within the stipulated timelines.
• Liaises with Client PV contact persons for medical device expedited reporting.
• Performing periodic literature and NPRA MADRAC/Journal search.
• Maintain Pharmacovigilance Log, Periodic Safety Updates Report Logs and Product Safety Core Data Sheet
• Responsible for reconciliation of PV logs with clients

Registered Pharmacist

• Responsible for supervising the discharge of psychotropic drugs
• Ensure company’s operations are in compliance with all Ministry of Health’s laws and regulations. Maintenance of the various licenses required to operate DKSH’s warehouse and distribution services.

Functional Skills and Knowledge

• Demonstrate knowledge in quality assurance tools, concepts and methodologies
• Demonstrate good knowledge in Dangerous Goods Regulations and Safety Data Sheets (SDS)
• Demonstrate basic understanding of the Global Harmonized System (GHS)
• Demonstrate 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.