Regulatory Affairs Specialist
1 week ago
As a Regulatory Affairs Associate, you will play a key role in supporting regulatory submissions and strategic projects across our diverse portfolio.
You will be based in Macquarie Park and join a close-knit, high-performing team that values collaboration, execution, and growth.
Main Responsibilities- Support regulatory submissions related to clinical trials, GMP, medicine shortages, and medical devices.
- Assist with data entry, documentation, and administrative tasks.
- Collaborate with internal stakeholders and external vendors to ensure compliance and timely delivery.
- Maintain regulatory databases and contribute to audit readiness.
- Participate in strategic projects and transversal initiatives.
- Build strong relationships with health authorities and regulatory bodies.
- Contribute to continuous improvement of regulatory systems and processes.
You have experience in regulatory affairs, clinical trials, or GMP within the pharmaceutical or biotech industry.
You thrive in collaborative, fast-paced environments and bring strong attention to detail and a focus on execution.
Excellent communication and teamwork skills are essential.
Proficiency in MS Office and database systems is required, as well as a natural inclination toward digital tools.
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