Regulatory Affairs Expert
2 weeks ago
We are seeking a highly skilled and motivated Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs group, you will play a crucial role in ensuring continuity of supply via life cycle maintenance activities for our existing portfolio and supporting the registration of new medicines in Australia.
The ideal candidate will have a Bachelor's degree or equivalent in Pharmacy, Science, or Chemistry, with at least two years' experience in regulatory affairs ideally with prescription medicines. They should also possess excellent communication skills (written and verbal) and be able to multitask and work to deadlines.
This role involves delivering regulatory submissions within required timeframes, maintaining compliance with relevant regulations and codes, and providing regulatory advice to company personnel as required. The successful candidate will also be responsible for collaborating cross-functionally to support submissions and projects, as well as supporting regulatory administrative activities and communicating safety practices.
Key Responsibilities:
- Deliver regulatory submissions within required timeframes;
- Maintain accurate and current databases and systems by drafting, updating, reviewing, and verifying entries;
- Ensure compliance with relevant regulations and codes and provide regulatory advice to company personnel as needed;
- Collaborate cross-functionally to support submissions and projects where required;
- Support regulatory administrative activities as needed;
We offer a competitive salary and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others.
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