Regulatory Affairs Executive

Established since 2006, BIG Pharmacy Healthcare Sdn Bhd has grown progressively from a neighborhood pharmacy to one of Malaysia’s leading pharmacy chain. We are expanding rapidly with over 300 hundred outlets throughout Malaysia. Big Pharmacy is the fastest growing community pharmacy in Malaysia. The group is poised for expansion nationwide with its strong management team, wide product range, and institutionalised pharmacist training program which formed the foundation of our successful business model.

Job Description:

  • Manage new product registration application with NPRA from preparation till approval.
    o Experience in generic category(poison and otc) is a must.
    o Preferred knowledge in TMHS and Cosmetic.
  • Submit BE Desktop Evaluation to NPRA.
  • Submit product classification to NPRA.
  • Submit product variation.
  • To handle post market surveillance activities.
  • Product label checking and application for food labelling screening and advisory, FSQD.
  • Maintain necessary or related records for regulatory department.
  • Coordinate and support Business Development team wherever necessary.
  • Product License renewal and cosmetic re-notification.
  • Indication certificate application.
  • MSC Trustgate Token application & renewal.
  • Any other job assigned by superior.


  • At least 5 years prior experience in Regulatory Affairs role.
  • Bachelor in any science discipline preferably (Pharmacy, Science or related fields)
  • An excellent communication skill in English and Bahasa Melayu.
  • Able to work independently with minimum supervision.
  • Knowledge in Medicine advertisements, KKLIU, GDP, GDPMD, Medical Device registration are an added advantages.
  • Willing to travel for work (within Klang Valley).

  Employment Type:  Full Time