Senior Regulatory Affairs Executive cum Quality Assurance

Senior Regulatory Affairs Executive cum Quality Assurance

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• Manage new product registration application with NPRA from preparation until approval.
  - Experience in generic category (poison and OTC) is a must.
  - Preferred knowledge in Medical Devices (MD), Traditional Medicines and Health Supplements (TMHS), and Cosmetics.
• To submit BE Desktop Evaluation to NPRA.
• To submit product classification to NPRA.
• To submit product variation.
• Product label checking and application for food labelling screening and advisory with FSQD.
• Maintain necessary or related records for regulatory department.
• Coordinate and support Business Development team wherever necessary.
• Renewal for Product License, Warehouse License, Import License and Cosmetic.
• Any other job assigned by superior.

Quality Assurance:

• Knowledge in GDP and GDPMD is a must.
• Incoming product inspection.
• To handle document and records control.
• To conduct supplier audit periodically, internal audit and handle audit by authority (NPRA & MDA).

Requirements:

• At least 2 years prior experience in Regulatory Affairs and Quality Assurance role.
• Medical Device-ads and JAKIM Halal are added advantages.
• Bachelor in any science discipline preferably (Pharmacy, Science or related fields).
• Excellent communication skills in English and Bahasa Melayu.
• Able to work independently with minimum supervision.

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Your application will include the following questions:

• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Regulatory Affairs Executive?
• Have you worked in a pharmacy before?
• Which of the following languages are you fluent in?

BIG Pharmacy has grown progressively from a neighbourhood pharmacy to one of Malaysia’s leading pharmacy chains. We are expanding rapidly with over 300 outlets throughout Malaysia.

Are you passionate about providing a great customer experience and educating customers to “Be In Goodhealth”? If yes, we want you to join us and grow with our BIG family!