Senior Regulatory Affairs Specialist
SRA24_1725336356
Posted: 09/03/2024
- Melbourne, Victoria
- Permanent
Senior Regulatory Affairs Associate, Senior RA Associate
Join a leading CRO as a Senior Regulatory Affairs Associate that's at the forefront of transforming global health and wellness! As the Senior Regulatory Affairs Specialist you will be part of an innovative team dedicated to delivering excellence across Clinical Trials, Regulatory Affairs, Medical, and Safety & Biometrics. This is your opportunity to collaborate with top-tier clients worldwide and leverage over a decade of industry success to drive change in healthcare.
Responsibilities:
- Prepare and submit Category 1 applications and regulatory variations (SAR, SRR, Category 3) for Australia (TGA) and New Zealand (Medsafe).
- Develop and submit Module 1 documents, including Product Information, Consumer Medicines Information, Product Labels, Risk Management Plans etc.
- Publish dossiers and variations in eCTD format using specialised software.
- Address queries from regulatory authorities promptly and accurately.
- Manage relationships with clients, TGA, Medsafe, and other key stakeholders.
- Stay current with global regulatory requirements and align company practices with these standards.
Skills:
- Bachelor's degree in Life Sciences, Pharmacy, or a comparable technical discipline.
- 5 years of experience in regulatory affairs in the pharmaceutical sector.
- Skilled in preparing Category 1 regulatory submissions.
- Proven history of successful regulatory submissions and product approvals.
Apply directly now, or send your updated CV to Ben Byrne at bbyrne@i-pharmconsulting.com OR (04) 21776703
Ben Byrne
Senior Recruitment Consultant
