Regulatory Affairs Associate

Candidates outside of Melbourne are encouraged to apply, on a fully remote basis! Step into a pivotal role as a Regulatory Affairs Associate with a leading CRO dedicated to driving global health advancements! Join a dynamic team where innovation and precision meet, focusing on Clinical Trials, Regulatory Affairs, and Safety & Biometrics. In this role, you'll work closely with world-renowned clients, shaping impactful healthcare solutions and making strides in the wellness sector on a global scale. Be part of a journey that's changing the future of healthcare!
Responsibilities: Perform gap review of regulatory dossiers.Preparation and submission of Category 1 applications in Australia (TGA) and New Zealand (Medsafe).Preparation and submission of regulatory variations (SAR, SRR & Category 3) & Category 1 applications in Australia and New Zealand.Preparation and submissions of GMP clearances.Publishing of dossiers or variations into eCTD using eCTD software.Development and organisation of technical files for medical devices.Skills: 1 - 2 years experience in Regulatory Affairs role.Experience of the preparation and submission of GMP clearances & regulatory variations.Dealt with clients and internal/external stakeholders.Apply directly now, or send your updated CV to Ben Byrne at ****** OR ABOUT i-PHARM CONSULTING i-Pharm Consulting is a specialist Recruitment Company servicing the global Life Sciences industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.
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