Job Description

Contract type:
Permanent


Location:
Petaling Jaya


Specialisation:

Pharmaceuticals


Salary:
RM48,000 - RM60,000 Annual


Reference:
PR/154084


Contact details:
Jing May How


Contact email:
jingmay.how@jac-recruitment.com


Job published:
January 20, 2023 10:30



JOB RESPONSIBILITIES

• Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
• Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
• Review technical dossier of new products and prepare additional documents where necessary.
• In-charge with the timely approval and renewal of product licences, company licenses, pre- and post-approval variations, permits and other applications.
• Provide appropriate solutions for compliance issues.
• Review and approve advertising and promotional items to ensure regulatory compliance.

• Degree qualification in life science related fields.
• Minimum 3 years\xe2\x80\x99 experience in Regulatory Affairs, experienced in registering health products, food supplement or chinese medicine will be added advantage.
• Ability to maintain confidentiality of sensitive areas.
• Ability to work independently, good communication and interpersonal skills.