Regulatory Submission Specialist (18-months contract)

Join our team of experts in regulatory and ethics submissions of clinical studies.  You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.We’re looking for a Regulatory Specialist on a 18-month contract to cover maternity leave. This is a great opportunity for someone looking to gain hands-on experience in clinical research.Office-based in Macquarie Park, SydneyYour role:Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications.Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters.Review translations of essential documents subject to clinical trial submission.Track the regulatory project documentation flow.Review documents to greenlight IP release to sites.Manage safety reporting to authorities.Deliver regulatory training to project teams.Assist with feasibility research and business development requests.