REGULATORY AFFAIRS EXECUTIVE

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Job Responsibilities:

1. Liaise with the government office, authorities and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits to developing new and existing products.
2. Responsible for collecting, gathering, compiling and preparing the materials needed (such as Common Submission Dossier Template - CSDT) for product registration and product renewal to the regulatory agencies MDA, NPRA and relevant overseas regulatory agencies in a timely manner.
3. Collaboration with Product Development team to strategically achieve and maintain a balance between regulatory concerns, marketing objectives, time to market, technology, compliance and costs.
4. Preparing submissions of various Regulatory applications, variations and change notifications to the relevant authority(s).
5. Maintain and track the registration status of all marketed products and all the regulatory activities planning.
6. Responsible to report to local authorities in a timely manner on post market surveillance activities such as Adverse event reporting, Field Safety Corrective Actions (FSCA) and Medical Device Recall.
7. Control promotional materials, labelling, storage and packaging requirements for compliance with applicable regulations and policies for existing product and new product development.
8. Identify and interpret relevant regulatory requirements. Evaluate applicable laws and regulations to determine impact on company activities.
9. Provide training and guidance to subordinate in regards to daily quality activities.
10. Any other tasks assigned by superior.

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Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• 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 role where you were responsible for authoring and reviewing technical documentation?
• Which of the following languages are you fluent in?
• How would you rate your Bahasa Malaysia language skills?
• How would you rate your English language skills?

Manufacturing, Transport & Logistics - 11-50 employees

Renal Laboratories is a subsidiary of the Excelsior Medical Healthcare group of Taiwan, a public listed company and the market leader in providing Dialysis Services in Taiwan, currently manages more than 150 dialysis centers with a total of 13,500 dialysis patients and 4,500 dialysis machines throughout Asia region.

Renal Laboratories (RL) began with the manufacturing facilities in 2010 located strategically in Bandar Enstek, Negeri Sembilan. RL is the manufacturer of dialysis concentrates, dialysis powders and cartridges.

The QMS of RL meets the requirements of the EN ISO 13485:2016, HALAL and MS ISO 13485:2017. RL facilitate with in-house QC Laboratory which compliance with ISO 17025.

What can I earn as a Regulatory Affairs Executive?