Your new company
This organisation is a rapidly growing, listed global biotechnology company with a strong presence in Australia. They are expanding their team and looking for senior regulatory associate to bring extensive regulatory knowledge and support the successful submission of new pharmaceutical products within the Oncology and Haematology field. This newly created position will report to the Regulatory Affairs Manager in Australia. This is a fully home-based opportunity and is open to any location in Australia.
Your new role
This organisation are looking for a Senior Regulatory Affairs Associate that will be responsible for the successful registration of new prescription products; both new applications/ indications. You will have an amazing opportunity to successfully register new clinical trials with a strong study pipeline. An integral part of this role will be the development and submission of documentation to TGA and Medsafe for review and approval. The team is made up of experienced and autonomous regulatory experts with strong industry links, a great learning environment. This role provides the opportunity to gain more exposure to regulatory landscape outside of the standard Senior RA role. Due to the company vision and product portfolio, there will be a strong focus on haem-onc trials.
What you'll need to succeed
What you'll get in return
- Extensive experience with NCE's and/or Cat 1 applications
- You will be confident in working autonomously and will be a motivated self-starter.
- Experience in writing and compiling all modules of a dossier
- Ideally you will have experience working with clinical trials submissions and applications
- Ideally you will have experience with oncology and/or haematology submissions
- A tertiary Life Sciences qualification.
This is an amazing opportunity to contribute and make your mark within Regulatory Affairs. You will be working for a innovative and expanding global company, with ambitious plans for growth indicating opportunities for development and doing it all from the comfort of your own home. The company reward high performers with an annual bonus, generous salary package and employee benefits.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.LHS 297508