Regulatory Affairs Professional (6-Month Contract) - Leading Global Pharmaceutical Org!
Work with a purpose-driven global healthcare company in Sydney dedicated to creating, improving, and prolonging lives.
This is a unique opportunity to join an organisation that develops innovative technologies in therapeutic areas such as Oncology, Neurology, and Fertility.
We are currently seeking a motivated Regulatory Affairs Associate or Senior Regulatory Affairs Associate for an initial 6-month contract to lead end-to-end strategies for a growing portfolio in rare diseases.
Working in the regulatory affairs team, you will play a pivotal role in leading the strategy and execution of regulatory activities that enable timely registrations and optimal labelling.
Your responsibilities will include:
- Managing pre-submission activities, Category 1 applications to the TGA and Medsafe.
- Perform dossier analysis, lead the strategy and execution of regulatory activities that enable timely registrations, optimal labelling and lifecycle management.
- Collaborate with local cross-functional, regional and global teams to facilitate successful registration, commercialisation and life cycle management of our products.
- Ensure compliance as per local regulations.
- Liaise with the TGA and Medsafe as required.
What we are looking for:
- Bachelor’s degree in life sciences, pharmacy, or a related field, with a minimum of 2-5 years of experience in Regulatory Affairs.
- Experience in leading the dossier and regulatory strategy for applications to the TGA and Medsafe.
- Ideally a proven track record of successful regulatory approvals, especially in rare tumours/diseases, including Orphan Drug Designation applications.
- Experience in leading interactions with the TGA and Medsafe that result in successful regulatory outcomes.
- Experience in drug development and clinical trial application or notification is highly regarded.
- In-depth knowledge of the Australian regulatory requirements for drug development and registration.
What's in it for you?
- Highly Competitive Daily Salary
- Be proud to represent a leading pharmaceutical global organisation of and be a part of two product launches into the Australian market!
- State of the art offices in Macquarie Park with on site parking
- Flexible & hybrid working arrangement
- Join a close knit high performing team
- Opportunities for this role to become permanent
- Immediate start: Start date from mid January 2026
Your next step
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to stephanie.iveson@randstad.com.au or call me now on 0410255454 to discuss your next role.
If this job isn't quite right for you but you are looking for a new position, please contact me for a confidential discussion about your career.
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
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