Regulatory Affairs Specialist
1 week ago
We are seeking a highly skilled regulatory affairs professional to fill this key position in Sydney. As a crucial member of our regulatory affairs team, you 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.
Key Responsibilities:- Deliver regulatory submissions within required timelines;
- Ensure company databases and systems are accurate and current by drafting, updating, reviewing and verifying entries;
- Maintain compliance with relevant regulations and codes and provide regulatory advice to personnel as needed;
- Collaborate cross-functionally to support submissions and projects where required;
- Support regulatory administrative tasks as necessary.
The successful candidate will have a Bachelor's degree or equivalent in Pharmacy, Science or Chemistry and at least two years' experience in regulatory affairs ideally with prescription medicines. They will also possess excellent communication skills, the ability to multitask and work to deadlines, and demonstrated ability to work effectively in a team environment.
Requirements:- Bachelor's degree or equivalent in Pharmacy, Science or Chemistry;
- At least two years' experience in regulatory affairs ideally with prescription medicines;
- Understanding of local and international regulatory guidelines;
- Capacity to investigate and evaluate problems to develop effective solutions;
- Excellent written and verbal communication skills;
- Ability to multitask and meet deadlines;
- Demonstrated ability to work collaboratively in a team environment and cooperate with others to achieve goals within specified timeframes.
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