Assistant Manager Regulatory Affairs

• Responsible for daily operation of product registration related activities, pharmacovigilance and controlled drug management for the Healthcare Business Unit of DKSH Singapore.
• Ensure all operational procedures are in compliance with the requirements of the local Regulatory Authorities.
• Registered pharmacist for the licences under the Health Products (Therapeutic Products) Regulation and Medicines Act.

• Pre-market activities: product assessment and new product registration.
• Post market activities: variation application, product licence renewal and maintenance.
• Permit application: named-patient permit, advertising permit & sale promotion permit and any permit to allow importation or exportation.

• Receive and review individual case safety report (ICSRs) for accuracy and completeness.
• Follow up with ...

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