Regulatory Affairs Executive

22 hours ago

Klang, Selangor, Malaysia Hovid Bhd Full time 60,000 - 120,000 per year

Job Title: Regulatory Affairs Executive / Pharmacist

Location: Ipoh or Petaling Jaya

Department: Regulatory Affairs

Reports To: Regulatory Affairs Manager

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:

1. Registration Matters

  • 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).

2. Regulatory Requirement Review

  • Monitor and assess updates in regulatory guidelines and communicate necessary changes to relevant departments.

3. Scientific Information Support

  • Conduct literature searches and gather scientific or technical information to support submissions and internal requests.

4. Pharmacovigilance Activities

  • Assist in monitoring and implementing pharmacovigilance (PV) requirements.
  • Support execution of pharmacovigilance-related activities, where applicable.

5. Administrative and Clerical Support

  • 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.

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