Aps 5 Scientific Officer – Listing Compliance Section Tga

About the companyListing Compliance Section (LCS) of the Complementary & OTC Medicines Branch (COMB) of the TGA is responsible for the regulatory compliance of listed and non-prescription medicines.​About the opportunityThe APS 5 Scientific Officer will be responsible for pre-market evaluations of scientific evidence, reviewing quality and safety, ensuring regulatory compliance, and post market compliance.This is a 12-month contract until April 22nd 2022.​DutiesConduct investigations and risk assessments into signals of potential breaches of therapeutic goods legislation.Exercise sound scientific judgement in recommending risk-based compliance enforcement actions to decision makers.Undertake compliance reviews of listed medicines, including preparing timely, high quality technical and scientific reports.Analyse internal compliance monitoring data to inform targeted compliance actions and compliance strategies.Maintain the section’s compliance databases, reports, and quality management system, including developing and maintaining Standard Operating Procedures.Prepare correspondence and education products for diverse stakeholders relating to regulation of low-risk medicines and outcomes of evaluations, reviews, and assessments.​Skills and ExperienceTertiary qualification in chemistry, pharmacology, nutrition, or relative science subjectExperience with TGA legislation and policy frameworksIdeally have experience with data analytics and relevant IT systemsAbility to support government teams in regulatory, legal or compliance environments.​