Regulatory Affairs Manager
4 semanas atrás
Job Title: Regulatory Affairs
At Intrials Clinical Research, we are seeking a highly skilled and experienced Regulatory Affairs professional to join our team.
Primary Responsibilities:
- Manage the Regulatory & Study Start-up team in all aspects, with support from the Regulatory and Study Start-up Manager (RSM).
- Support RSM in defining metrics and KPIs for the Regulatory & Study Start-up department.
- Support RSM in preparing and maintaining financial projections and monitor results.
- Support RSM in preparing and maintaining resources projections and monitor results.
- Define staff allocation for regulatory and start-up activities to PMs, and discuss allocation with PMs.
- Provide support, mentoring, coaching, and training to the Regulatory & Study Start-up team involved in clinical trials.
- Ensure the Regulatory & Study Start-up team conducts clinical trials in accordance with ICH-GCP guidelines, local and international regulations, and Intrials' and Sponsor's SOPs.
- Ensure clinical trials regulatory and start-up activities follow forecasted activities, timelines, milestones, and contract budget.
- Member of ABRACRO (CRO Brazilian Association) and/or CTNBio in Brazil, if required.
- Participate in RFPs development and attend bid defense meetings, if required.
- Act as Intrials governance point of communication for the Sponsor during project development and conduction, with RSM support.
Requirements:
- University degree in a health-related area.
- Solid professional experience working in Regulatory and Start-up activities for Clinical Trials in pharmaceutical companies or CROs.
- Good knowledge of clinical trials local and international regulations applicable to Latin America.
- Professional experience with clinical trials procedures for studies phases I-III and ICH-GCP.
- Professional experience with country regulations for LECs, MOH, and other regulatory bodies applicable for clinical trials approval.
- High Intermediate or Advanced English.
- Spanish will be considered an advantage.
- Knowledge of Microsoft Office, Excel, and Adobe Acrobat software.
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