Regulatory Submissions Associate Manager II - APAC
Remote · Sydney, New South Wales, Australia or South Korea
Job Summary
Regulatory Submissions Associate Manager II for APAC responsible for oversight of RA, IRB/EC and Third Body submissions across the APAC region, including submission strategy, timelines, and delivering to milestones; provide regulatory guidance to project teams, liaise with RA/IRB/Third Bodies, manage CTIS/EU CTR application considerations (where applicable), monitor start-up plans, ensure regulatory deliverables meet timelines, support audits/inspections, mentor junior team members, and contribute to process improvements within a hybrid, globally-traveling environment.
Required Qualifications
- Bachelor’s Degree in Life Sciences or equivalent
- Minimum 4 years of experience in the Pharmaceutical/CRO industry in Clinical trial Regulatory Affairs
- Experience in RA, IRB/EC, and Third Body submissions, including submission strategy, timeline, and planning
- Solid expertise in QC of regulatory submission packages
- Confident communicator and a high attention to detail
- Hybrid working (dependant on location)
- Global travel required 5% of the time, which will require an overnight stay
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