Regulatory Affairs Associate
RAA24_1726985051
Posted: 22/09/2024
- Melbourne, Victoria
- Permanent
Regulatory Affairs Associate, RA Associate
Candidates outside of Melbourne are encouraged to apply, on a fully remote basis!
Join a premier CRO as a Regulatory Affairs Associate and be part of a team that's transforming global health and wellness! In this role, you'll contribute to an innovative group focused on excellence in Clinical Trials, Regulatory Affairs, and Safety & Biometrics. This is your chance to collaborate with esteemed clients around the world and play a vital role in advancing healthcare solutions.
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 bbyrne@i-pharmconsulting.com OR (04) 21776703
Ben Byrne
Senior Recruitment Consultant
