Executive Regulatory Affairs

DKSH; Selangor; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading healthcare company in Malaysia is seeking a Regulatory Affairs Pharmacist to assist in managing regulatory matters. The role involves submission of regulatory variations, liaising with local authorities, and ensuring compliance with government regulations. Candidates should possess a Bachelor's Degree in Pharmacy and demonstrate knowledge of quality assurance and local regulations. Proficiency in English and cultural sensitivity are also required. This position offers an opportunity to work in a dynamic regulatory environment.

Qualifications

• 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 of local regulations.
• Proficient in office productivity tools (Excel, Word, PowerPoint).
• Show appreciation and respect for cultural sensitivities, especially in cross-country/cultural interactions.
• Fluency in local language and ideally in English, both written and spoken.

Responsibilities

• Assist in timely variation submission via NPRA Quest system for pharmaceutical products.
• Liaise with local Regulatory Authorities for regulatory approvals.
• Ensure DKSH (M) operations comply with government laws and regulations.
• Review promotional material to ensure compliance with guidelines.

Skills

Knowledge in quality assurance tools

Understanding of Dangerous Goods Regulations

Basic understanding of Global Harmonized System (GHS)

Working knowledge of local regulations

Proficient in Excel

Proficient in Word

Proficient in PowerPoint

Fluency in local language

Fluency in English

Cultural sensitivity

Education

Bachelor's Degree in Pharmacy

Job description

Job Overview

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

Key Responsibilities

• Regulatory Affairs:
  • Assist in timely variation submission via NPRA Quest system for pharmaceutical products, product registration maintenance, and document retention.
  • Keep abreast of updated regulations in Malaysia.
  • Liaise with local Regulatory Authorities to expedite early regulatory approvals and serve as official liaison personnel with 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 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):
  • Act as local Pharmacovigilance associate supporting Primary PV responsible person.
  • Liaise with Client PV contact persons for timely reporting of Adverse Drug Events and submit reports within stipulated timelines.
  • Handle medical device expedited reporting.
  • Perform periodic literature and NPRA MADRAC/Journal search.
  • Maintain Pharmacovigilance Log, Periodic Safety Update Reports, and Product Safety Core Data Sheet.
  • Reconcile PV logs with clients.
• Registered Pharmacist:
  • Supervise the discharge of psychotropic drugs.
  • Ensure company’s operations are in compliance with Ministry of Health laws and regulations, and maintain necessary licenses for warehouse and distribution services.

Qualifications & Skills

• 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 of local regulations.
• Proficient in office productivity tools (Excel, Word, PowerPoint).
• Show appreciation and respect for cultural sensitivities, especially in cross-country/cultural interactions.
• Fluency in local language and ideally in English, both written and spoken.

Education

• Minimum Bachelor's Degree in Pharmacy.