Officer – Regulatory affairs

Job Responsibilities

• To ensure application of block list in drug authority database for RM/PM.
• To ensure documents endorsement from drug authority to release customs for RM/PM.
• Preparing submissions for NOC (No objection Certificate) from different regulatory authorities.
• Liaise with Plant team to get documents for different application.
• Have ability to review the documents for different application as per drug authority guidelines.
• Documentation and other requirements for support for market access.
• Manage the activities of Regulatory Affairs within the field of responsibility, including preparation, co-ordination and following-up of the necessary documentation and/or supplements needed for regulatory agency submissions.
• Other duties as assigned.