Nadia Kaienua

Biography

I have worked at Roche for around seven years, starting off in Regulatory Compliance and moving through to my current role as a Regulatory Affairs Product Manager. In my role I work as part of the Regulatory Affairs team for Australia and New Zealand. In New Zealand, every medicine sold must first be registered with the Ministry of Health (Medsafe), and it is my job to ensure this is the case. I review the medicine dossier against NZ legislation and guidelines and determine a strategy to bridge any gaps. I adapt sections of the dossier to fit local requirements before finally submitting the registration application to Medsafe for review. Medsafe evaluates aspects such as the manufacturing and testing of the medicine (quality) as well as the benefit-risk profile (efficacy and safety) of the medicine as observed in clinical trials (and also in the post-market setting for registered medicines). Once registered, the medicine can then be made available to New Zealand patients.

Research Interest

Any further changes to the quality, safety or efficacy aspects of the medicine once it is registered may also need to be reviewed and approved by Medsafe. I assess whether or not these changes need to be registered; obtaining additional documentation and determining what impact the change may have; before submitting the application to Medsafe to ensure Roche can continue to supply the medicine. I am also involved in submissions and obtaining approvals for Roche to be able to run clinical trials; giving New Zealand patients an opportunity to receive a medicine which may otherwise not be available to them.