Senior Regulatory Affairs Executive

• 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.

Requirements:

• At least 2-3 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).