Regulatory Advisor

2 weeks ago


Wellington, Wellington, New Zealand New Zealand Government Full time

About the Role

We are seeking a highly skilled Regulatory Advisor to join our team. As an Advisor, Product Safety, you will play a pivotal role in monitoring potential quality issues, ensuring compliance with legislation, and managing corrective actions including recalls.

Key Responsibilities

  • Investigate Medicine Quality Issues: Review, risk assess, and act on reports of quality concerns and breaches of medicines legislation.
  • Oversee Complaints & Recalls: Manage the complaints and recall process, ensuring adherence to internal SOPs and the New Zealand Recalls Code.
  • Provide Technical Advice: Collaborate with teams to deliver accurate, risk-based decisions and advice on medicines.
  • Regulatory Action & Compliance: Assist in regulatory action, including preparing materials for prosecutions and reviewing therapeutic advertisements for compliance.
  • Drive Improvements: Contribute to projects, process development, and continuous improvement across the Product Safety framework.

Requirements

  • A relevant tertiary qualification, preferably pharmacy or other sciences with an emphasis on medicines.
  • Working knowledge of the regulation of medicines and management of post-market quality systems ideal, but is not essential.
  • Experience, or interest in, working in a regulatory environment.
  • Ability to develop working relationships within the health sector and industry.
  • Strong written and oral communication and influencing skills, with the ability to communicate to different target groups including consumers.

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