Regulatory Affairs Officer, Mat Leave Contract, Csl
6 months ago
**Contract Detail**:
- Duration of role - 12 months initially but could go longer
- To start asap but will wait for right person
- Reason for vacancy? Maternity Leave Backfill
- Role reports to (title)? Associate Director, Regulatory Regional ANZ TA Lead
- Department? Global Regulatory Affairs
- Team size? Immediate team of 4, but will work across different teams in APAC so 15 in total
- Work from home?: Some flex to do some hours from home (approx. 2 from home once trained) 3 days min in office and Thursdays will need to be in office
- Hours? Standard Mon to Fri hours, possibly occasionally will need to attend a meeting via Teams outside of working hours for global calls
- Time off in lieu for a global call - won’t be often
- Location? CSL Melbourne
**Role**:
- Supporting the wider regulatory Affairs team in APAC not just the current team
- Preparation, compilation and submission of Marketing Application and variations for new or life cycle products or other documentation
- Help prepare the regulatory component of the life cycle documents such as PSURs, annual reports.
- Prepare dossier preparation check/tracking lists and if necessary, requests missing documents from the operational departments including monitoring of deadlines.
- Help review guidelines and coordinating/preparing comments.
- Work with the product managers/specialists in preparing Module 1 documentation.
- Data entry and maintenance in/of regulatory systems (databases, sharepoints, etc) and to provide outputs for eg audit requests.
- Work with relevant product managers/scientists to prepare standard operating procedures/work instructions or check/tracking lists.
- Work with the team leads or delegate to monitor the metrics/statistics, reports etc. for presentation purposes.
- Work with managers/team leads to monitor training requirements and be the interface with the GRA and local training departments.
***
**Must haves**
- Entry level - 1 years tertiary science or proven regulatory experience
- Function-related training in Regulatory Affairs
- Flexibility to work in a global regulatory cross cultural work environment
- Team player with a demonstrated ability to develop constructive and effective relationships
- Awareness of regulatory affairs
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