Regulatory Affairs Executive (Ipoh or PJ)

Hovid; Selangor; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading Malaysian pharmaceutical company is seeking a Regulatory Affairs Executive/Pharmacist to join their team in Ipoh or Petaling Jaya. This role entails supporting product registration and ensuring compliance with regulatory standards. Candidates should possess a Bachelor’s Degree in Pharmacy or related field, with 1-3 years of experience in Regulatory Affairs. Strong communication skills in English and Bahasa Melayu are essential, along with a detail-oriented and organized approach. The company offers a competitive remuneration package and a supportive work environment.

Benefits

Competitive remuneration and benefits package

Collaborative team environment focused on professional growth

Exposure to local and international regulatory processes

Qualifications

• 1-3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Ability to work independently or as part of a team.

Responsibilities

• Obtain and maintain marketing authorizations for products.
• Prepare product dossiers for regulatory submissions.
• Liaise with regulatory authorities and distributors.

Skills

Excellent written and verbal communication skills in English and Bahasa Melayu

Strong understanding of pharmaceutical regulations

Highly organized

Detail-oriented

Education

Bachelor’s Degree in Pharmacy, Science, or related discipline

Job description

Regulatory Affairs Executive (Ipoh or PJ)

Job Title: Regulatory Affairs Executive / Pharmacist

About the Role: We are seeking a Regulatory Affairs Executive/Pharmacist to join our Regulatory Affairs team based in Ipoh or Petaling Jaya. The role involves supporting product registration, maintaining regulatory compliance, and ensuring all products meet current regulatory standards. This position offers exposure to both local and international regulatory processes in a dynamic pharmaceutical environment.

Key Responsibilities:

• Obtain and maintain marketing authorizations for all categories of products regulated by drug authorities worldwide.
• Organize and prepare product dossiers for regulatory submissions to designated countries.
• Liaise with regulatory authorities, distributors, agents, and suppliers on submission requirements, documentation, and progress updates.
• Manage the full process from dossier submission to approval, including post-approval variations and amendments.
• Handle renewals of marketing authorizations and maintain valid registrations.
• Apply for relevant licenses and certificates as required.
• Review and verify finished product artwork for regulatory compliance (if required).
• Monitor and assess updates in regulatory guidelines and communicate necessary changes to relevant departments.
• Conduct literature searches and gather scientific or technical information to support submissions and internal requests.
• Assist in monitoring and implementing pharmacovigilance (PV) requirements and support execution of related activities.
• Provide general administrative assistance to ensure smooth operation of the Regulatory Affairs Department.

Requirements:

• Bachelor’s Degree in Pharmacy, Science, or a related discipline.
• Preferably 1–3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of pharmaceutical regulations, legal requirements, and manufacturing processes.
• Excellent written and verbal communication skills in both English and Bahasa Melayu.
• Highly organized, detail-oriented, and able to work independently or as part of a team.

Why Join Us?

• Be part of a leading Malaysian pharmaceutical company with a strong reputation for quality and compliance.
• Gain regional exposure to both local and international registration processes.
• Collaborative and supportive team environment focused on professional growth.
• Competitive remuneration and benefits package.

Note: Only shortlisted candidates will be notified.