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 (04) 21776703 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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