Regulatory Manager

Job Description

1. To manage the regulatory department and develop processes so that new chemical entities, new dosage forms and new indications are registered in a timely fashion.
2. Overall responsibility 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.
3. Ensure that all state and federal regulatory requirements are addressed for the clinical research programme and for marketed products.
4. Develop professional relationships with TGA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
5. Provide regulatory expertise to clinical project teams (CTN applications, importation of clinical trial material, reporting of adverse events).
6. Provide Australian regulatory expertise to global product development teams.
7. Conduct training sessions for CRAs and sales representatives on ADR reporting and the importance of pharmacovigilance.
8. 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.