Specialist, Regulatory Operations - Remote

Overview

The Specialist, Regulatory Operations will oversee and execute all site-level regulatory operational activities for assigned clinical trials in the U.S., ensuring compliance with applicable U.S. regulations and guidelines.

In Short

• Oversee regulatory operations for clinical trials.
• Ensure compliance with FDA and OHRP regulations.
• Coordinate preparation and review of essential records.
• Provide regulatory guidance to site operations teams.
• Support IRB site level submissions and approvals.
• Track essential records and timelines.
• Collaborate with cross-functional teams.
• Identify process gaps and support improvement.
• Work independently in a fast-paced environment.
• Contribute to departmental success through KPIs.

Requirements

• Bachelor's degree in a scientific or healthcare-related field.
• Minimum of 2 years of experience in regulatory affairs.
• Understanding of U.S. regulations and ICH GCP guidelines.
• Experience in managing IRB submissions.
• Good computer skills, including MS Word and Excel.
• Detail-oriented with problem-solving abilities.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a team.
• High level of self-motivation and energy.
• Proactive approach to regulatory challenges.

Benefits

• PTO/vacation days, sick days, holidays.
• 100% paid medical, dental, and vision insurance.
• 75% coverage for dependents.
• HSA plan.
• Short-term and long-term disability insurance.
• 401k retirement plan.
• Culture of growth and equality.