Regulatory Assistant

Job Description

1. Assist Regulatory Associates with the preparation of regulatory documentation including 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. Ensure that serious adverse events are dealt with in a speedy fashion according to Standard Operating Procedures ie reviewed by CRA and Medical Director and reported to Ethics committees and regulatory bodies within specified timeframes.
3. Ensure that all other adverse event data (trial, literature and spontaneously reported) is entered into corporate global regulatory databases within the timeframes specified and that the appropriate regulatory authorities are notified.
4. Assist with the smooth management of the company’s Special Access Schemes.
5. Assist Clinical Research Associates with the preparation of Ethics committee submissions, CTN applications and other required documentation.