
Regulatory Affairs Coordinator
6 days ago
We are committed to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles.
This role is responsible for quality deliverables at the country level, following project requirements and applicable country rules with minimal oversight from the SSU Country Manager. The ideal candidate will have excellent understanding of clinical trial process across Phases II-IV and ICH GCP, good understanding clinical protocols and associated study specifications, and strong organizational skills with proven ability to handle multiple projects.
The job responsibilities include forecasting submission/approval timelines, ensuring compliance and tracking milestone progress in agreed upon SSU tracking system in real time. The candidate must be able to analyze data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalate the issue as soon as identified.
Additionally, the role involves monitoring financial aspects of the project and the number of hours/tasks available per contract, reviewing and complying with Standard Operating Procedures (SOPs) and Work Instructions (WI), and ensuring all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
The successful candidate will have line management/mentoring responsibilities and may act as Country Delivery Lead, responsible for operational delivery across the county portfolio for country participation through to site start up and ending in site activation and First Patient In.
- Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SAL.
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