Senior Regulatory Start Up Associate

Description

• Serve as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects.
• Provide expertise and guidance to RSM and/or PM on country and local regulations and practices, keeping abreast of developments and changes in regulations, guidelines and practices surrounding clinical trial approvals in relevant countries.
• Work within the scope of the Regulatory Start-Up plan or other applicable project plan, relevant SOPs, and ICH-GCP.
• Provide country and site level information on submission deadlines and timeline metrics for local Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
• Works within forecasted submission/approval timelines and ensures they are complied with, updating appropriate systems accurately and in a timely manner, including planned and actual dates of submissions/approvals.
• May serve as a point of contact with investigative sites for Regulatory Authority, Ethics Committees/Review Boards and other local authority related activities.

Qualifications

• Graduate in a clinical, pharmacy or life sciences related field.
• At least 1 year of related experience in either a CRO, pharmaceutical or clinical/hospital environment in Australia.
• Confident English written and verbal communication style.
• Ability to work across multiple IT applications and databases.