概述

• 薪资

  4,000 SGD ~ 5,000 SGD

• 产业类别

  Manufacturing(Pharmaceutical/Medical Equipment)

• 工作内容

  Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs & Quality Management (Compliance) Executive. The primary responsibilities of this role include managing regulatory compliance, pharmacovigilance, and quality management, as well as liaising with health authorities and overseeing product inspections.
  
  You will be reporting to the Manager.
  
  【 Responsibilities 】
  - Stay updated on local regulatory requirements and ensure compliance, liaising with global and regional teams.
  - Review and forward safety events to Global PV and local health authorities, following SOPs and regulations.
  - Identify safety information from literature sources and support local RMP and PV activities.
  - Assist in the creation and management of the local PSMF.
  - Liaise with investigational sites regarding safety issues and develop PV training materials.
  - Maintain agreement PV clauses and manage Aggregate Report submissions to local authorities.
  - Reconcile safety information with internal and external functions and support audits, deviations, and CAPAs.
  - Develop and maintain the PV Business Continuity Plan.
  - Act as the primary contact for local health authorities and prepare registration dossiers for regulatory approvals.
  - Review product change requests and labelling for compliance with regulations.
  - Provide regulatory input to develop local strategies and ensure SOP compliance.
  - Manage GDP operational quality, including product releases, holds, and recalls.
  - Lead or support GDP inspections and manage outsourced activities to meet standards.
  - Review promotional materials for compliance.