Regulatory Associate

Job Description

1. Responsible for compiling regulatory submissions to the TGA, drafting Product Information, Consumer Information, literature searches to support submissions, TGAL product analysis, changes in manufacturing, pack sizes, CPI and PI development, packaging changes, MIMS notification and other regulatory activities.
2. Provide regulatory expertise to clinical project teams (CTN applications, importation of clinical trial material, reporting of adverse events).
3. Train sales representatives on ADR reporting and the importance of pharmacovigilance.
4. Working with marketing to ensure that the content of all promotional material is fully supported by the Product Information and literature, and in accordance with the guidance offered by the Medicines Australia Code of Conduct.