Regulatory Affairs Pharmacist

Job Responsibilities

1. Responsible for maintaining registration of Therapeutic Pharmaceutical Products, Cosmetic Products, Health Supplements, Traditional Products, Chinese Proprietary Medicine, Medical Devices, and other categories of Health Products subjected to licensing by Authorities of Malaysia, Singapore, and countries where the products are exported to.
2. Responsible for registration of new Therapeutic Pharmaceutical Products, Cosmetic Products, Health Supplements, Traditional Products, Chinese Proprietary Medicine, Medical Devices, and other categories of Health Products subjected to licensing by Authorities of Malaysia, Singapore, and countries where the products are exported to.
3. Deal with suppliers from overseas pertaining to registration matters of all imported products.
4. Deal with BE centres in matters pertaining to BE studies.
5. Establish contract agreements for contract manufacturing and support registration of contract manufactured products and repacking processes.
6. Responsible for DD, PSY, and Precursor raw material – Quota application, import and export permit as well as monthly report to authority.
7. Monitor work progress of registration executives, registration officers, and registration clerks and provide solutions/advice when they encounter problems.
8. Develop new SOPs for work processes within the department and interdepartmentally.
9. Keep abreast of the latest regulatory information and requirements and disseminate to stakeholders.
10. Support post-marketing surveillance (PMS) issued by authority.
11. Maintain good up-to-date documentation and submission practices.
12. Other tasks assigned by superior from time to time.

Experience Requirements

More than 4 years experience in Regulatory Affairs in the Pharmaceutical field.

Location

Location can be PJ/JB depending on candidate availability.

Company Overview

Our company is a manufacturer and marketer of healthcare products. We have two generic pharmaceutical production factories, the first manufacturing factory established in Singapore (established in 1968) and the other in Malaysia (established in 1978). Our sales representation covers Doctors, Hospitals, Medical Centers, pharmacies, and wholesalers. In order to promote our own products brand as well as products from principals that we represent, we also export our products to other Asian countries.

Why Join Us?

Join us to make an improvement in millions of people’s lives. Not many jobs offer you more of a chance to do this. Developing, manufacturing & promoting pharmaceutical products is a team effort, combining the talent of many individuals. We have a long history of excellence, and you will see potential opportunities for career growth, internal transfer, or promotion.

Benefits

• Attractive salary package and other benefits such as H&S and PA Insurance coverage.
• Long service award to appreciate loyalty.
• Annual Dinner and Company Trip to appreciate our staff’s hard work.
• 5 days work per week.