Regulatory Affairs Specialist
2 weeks ago
This is an exciting opportunity to join our team as a Regulatory Affairs Specialist. The successful candidate will be responsible for ensuring the 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 in Pharmacy, Science or Chemistry, with at least two years' experience in regulatory affairs ideally with prescription medicines. They should have a strong understanding of local and international regulatory guidelines and excellent communication skills (written and verbal).
As a key member of our team, you will be responsible for delivering regulatory submissions within required timeframes, ensuring company databases and systems are accurate and current, and maintaining compliance with relevant regulations and codes. You will also provide regulatory advice to company personnel as required and support special projects and collaborations with cross-functional teams.
Our team offers competitive salaries, benefits and a supportive work environment where you can grow and develop your skills and experience. We strive to make a positive impact on people's lives and we invite you to be part of this journey.
Key responsibilities include:
- Deliver regulatory submissions within required timeframes;
- Ensure company databases and systems are accurate and current by drafting, updating, reviewing and verifying entries;
- Ensure our company's change control system is accurate and current by creating, reviewing and/or completing change records as required;
- Maintain compliance with relevant regulations and codes and provide regulatory advice to company personnel as required;
- Maintain compliance and up-to-date training with internal Policies, Standard Operating Procedures, and Work Instructions, and adhere to company values and expectations;
- Complete allocated special projects;
- Collaborate cross-functionally to support submissions and projects where required;
- Support regulatory administrative activities as needed;
- Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.
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