Regulatory Advisor
6 days ago
- Wellington Based | Permanent | Full-time
- 4.4 weeks annual leave | Wellness allowance
- Salary: $91,501 (dependent on experience)
Ko ake mahi - What you'll do
You will be at the forefront of safeguarding the quality and safety of medicines in New Zealand. 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.
Your 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 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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