Senior Regulatory Affairs & Compliance – Clinical Research

001 University of Rochester; United States; On-site; USD 71,000 - 106,000; Full time

Job summary

University of Rochester is seeking a Senior Regulatory Affairs and Compliance Specialist to oversee regulatory submissions and ensure FDA IND/IDE compliance across clinical studies. You will manage quality systems, SOPs, and coordination with sponsors, PIs, and administrative offices.

The role requires a Bachelor's degree with 5 years of regulatory experience; a Master's is preferred. CLASP certification is required, and the position sits in the Clin & Translational Science Institute with

Qualifications

• Bachelor's degree and 5 years of regulatory-related experience required
• Master's degree preferred or equivalent combination of education and experience
• CLASP certification is required

Responsibilities

• Coordinate regulatory submissions for new and ongoing studies
• Ensure compliance with FDA IND/IDE regulations and GCP guidelines
• Develop and maintain SOPs and regulatory documentation
• Interact with PIs, sponsors, and administrators on regulatory matters
• Monitor regulatory requirements and prepare submissions to ClinicalTrials.gov and other agencies
• Provide training and guidance on regulatory updates to teams
• Lead and participate in audits and CAPA processes

Skills

Regulatory affairs

FDA IND/IDE

SOP development

Stakeholder engagement

Regulatory submissions

Quality systems

Project coordination

Attention to detail

Education

Bachelor's degree

Master's degree preferred

CLASP certification

Job description

University of Rochester is seeking a Senior Regulatory Affairs and Compliance Specialist to oversee regulatory submissions and ensure FDA IND/IDE compliance across clinical studies. You will manage quality systems, SOPs, and coordination with sponsors, PIs, and administrative offices.

The role requires a Bachelor's degree with 5 years of regulatory experience; a Master's is preferred. CLASP certification is required, and the position sits in the Clin & Translational Science Institute with