Regulatory Operations Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB as assigned under supervision.

• Act as the primary liaison with the Sponsor/CRO while negotiating the IC for IRB submission.

• Function as the main contact with the IRB for the studies.

• Log work activities in Regulatory Operations tracking systems and generate status reports as needed.

• Address inquiries and follow up on outstanding items.

• Prepare and submit study documents to the IRB for assigned studies under supervision.

• Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned under supervision.

• Serve as the primary point of contact with the IBC for the studies.

• Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned under supervision.

• Maintain the Investigator Site File (ISF) (paper and/or electronic) for assigned studies.

⛳️ Requirements

• High School Diploma/GED

• Five years of experience in a regulatory research environment

• Proficient working knowledge of Microsoft Outlook 365

• Previous experience with regulatory document management systems (e.g., Veeva, Advarra E-Reg)

• Strong organizational skills and a commitment to timely project completion

• In-depth understanding of medical and clinical research terminology.

🏝️ Benefits

• Comprehensive health coverage: Medical, dental, and vision insurance provided

• Robust retirement planning: 401(k) plan available with employer matching

• Financial security: Life and disability insurance for added protection

• Flexible financial options: Health savings and flexible spending accounts offered

• Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided