regulatory affairs executive

6 days ago


Bandar Baru Bangi, Selangor, Malaysia Y.S.P. Industries (M) Sdn Bhd Full time

Responsibilities:

1) Ensure that company's products comply with the applicable regulations.

2) Maintain and update pharmaceutical related legislation, guidelines and customer's requirements. 

3) Responsible for compilation of dossier in a timely manner for new product registration, product amendment and product license renewal.  

4) Monitor product registration status and ensure validity of registrations. 

5) Maintain close liaison with regulatory authorities and overseas agent for all matters pertaining to registration and regulatory. 

6) Support the teams by providing advices on regulatory requirements and strategy. 

7) Other regulatory tasks as assigned by superior.

Requirements:

1) Degree qualification in Science or Medical-related discipline. 

2) Fresh graduates are welcomed to apply however candidate with Regulatory Affairs experiences would be an added advantage. 

3) Strong communication and negotiation skills.

4) Excellent time management and punctuality. 

5) Demonstrate proficiency in office productivity tools (e.g. Excel, Word and PowerPoint). 

6) Demonstrate fluency in Bahasa Malaysia and English, both written and spoken.



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