Remote Senior Regulatory Operations Specialist

Care Access; United States; Remote; USD 90,000 - 100,000; Full time

Benefits offered by this job

PTO & Holidays

Medical, dental, vision insurance

401(k) retirement plan with company 
匹

HSA contributions

Job summary

Care Access is seeking a Senior Specialist, Regulatory Operations to join the Global Regulatory Operations Team. This remote role supports U.S. sites and may assist Canadian sites, ensuring compliance with FDA and global standards throughout trial lifecycles.

You will oversee regulatory activities, prepare submissions, maintain DOA logs, and collaborate with Quality and Clinical Operations to meet KPIs and regulatory readiness.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field is required; advanced degree preferred or equivalent experience.
• Proven ability to support IRB submissions and regulatory document preparation.
• Experience with U.S. regulatory requirements and site operations.

Responsibilities

• Provide regulatory advice and lead regulatory project work.
• Support compliance for U.S. clinical research sites with FDA/OHRP standards.
• Coordinate IRB submissions and maintain approvals throughout studies.

Skills

Regulatory communications

Team collaboration

MS Word

Excel

Regulatory submissions

Independent work

Education

Bachelor's degree in a scientific or healthcare-related field

Tools

Clinical trials database

Job description

Care Access is seeking a Senior Specialist, Regulatory Operations to join the Global Regulatory Operations Team. This remote role supports U.S. sites and may assist Canadian sites, ensuring compliance with FDA and global standards throughout trial lifecycles.

You will oversee regulatory activities, prepare submissions, maintain DOA logs, and collaborate with Quality and Clinical Operations to meet KPIs and regulatory readiness.