Manager, Regulatory Operations

📋 Description

• Lead, coach, and develop Regulatory Operations team members, including specialists and assistants
• Partner with Regulatory Operations leadership and Quality Assurance to establish departmental goals
• Oversee regulatory submissions to ensure accuracy, completeness, compliance, and timely delivery
• Develop, maintain, and improve standard operating procedures (SOPs), work instructions, templates
• Manage relationships and serve as a key point of contact for IRBs, Institutional Biosafety
• Oversee the preparation and submission of new study applications, informed consent documents

🎯 Requirements

• Bachelor's degree or equivalent relevant professional experience in lieu of a degree.
• At least 5 years of progressively responsible experience in a regulatory research environment
• Demonstrated experience leading or supervising teams, coordinating workloads, and supporting
• Advanced working knowledge of IRB, FDA, and IBC requirements, as well as applicable Good Clinical
• Experience maintaining inspection-ready regulatory documentation and supporting audits or
• Proficiency with Microsoft Office and regulatory data-tracking or document-management systems, such

🎁 Benefits

• Annual base salary: $110,000–$135,000, with the final offer depending on factors such as location
• Eligibility for an annual performance bonus based on role and organizational results.
• 401(k) retirement savings plan with employer matching.
• Generous paid time off and paid holidays.
• Comprehensive medical, dental, and vision insurance, with optional additional insurance coverage.
• Employer-paid life and disability insurance.