Regulatory Affairs Manager

This opportunity is with a LEADING cancer research center! They are looking to add a dedicated Regulatory Affairs Manager to their team to support their leading investigators and exciting clinical studies. This organization is looking to interview as soon as possible!Description:

Maintain quality control functions and monitoring compliance for research studies

Proactively address issues to ensure overall integrity in document management through quality and compliance checks

Work collaboratively with key stakeholders, as well as, colleagues across the research enterprise.

Oversee assigned service lines (workflow processes) and track regulatory activation milestones and timelines

Promote timeline and compliant opening of new studies in additional to providing oversight of clinical trials by actively monitoring approvals, document creation, sponsor relationships and overall study management from a regulatory perspective

Supervisor day to day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring and evaluation of work product

Provide quality reviews and oversight functions for all IRB submissions and post approvals to ensure regulatory integrity, while evaluating submissions metrics and staff feedback to identify gaps

Manager regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions and special projects related to efficiency and compliance within reg group

Skills & Qualifications:

4 year degree in any discipline- Science preferred but not required

4+ years of regulatory experience - IRB, coordinating, submissions, etc

Oncology experience

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