Regulatory Compliance Specialist

2 weeks ago


Wellington, Wellington, New Zealand New Zealand Government Full time

**About the Role**

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

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.

Required Skills and Qualifications

  • 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.

About Us

We are the kaitiaki of the health system, providing leadership and driving strategy and performance. We regulate the health sector and are the primary source of advice on health matters.



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