Specialist, Regulatory Operations

Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience. Minimum of 2 years of experience in operational regulatory affairs within the research site, CRO, or pharmaceutical industry. Understanding of U.S. regulations and ICH GCP guideline as they relate to site operations. Good knowledge of site-level regulatory requirements for clinical trials in the U.S. Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance. Ability to communicate and work effectively with a diverse team of professionals. Good verbal and written communication skills. Team Collaboration Skills. Good computer skills with demonstrated abilities using clinical trials database, MS word and excel. Experience in electronic Investigator Site Files systems like (Florence, CRIO). Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done. Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. High level of self-motivation and energy. Ability to work independently in a fast-paced environment with supervision. Must have a client service mentality. Detail-oriented with good problem-solving abilities and a proactive approach to regulatory challenges. Ability to handle multiple tasks in a fast-paced and constantly changing environment.

Act as main regulatory operations contact for assigned studies. Support regulatory compliance for U.S. clinical research sites. Coordinate preparation and review of key site essential records. Assist in preparing for sponsor monitoring visits. Provide regulatory guidance to site operations teams. Track essential records and timelines. Support sites through the Site Evaluation Visit, Site Initiation Visit, and Study Closeout. Coordinate and perform IRB site level submissions and maintenance of approvals. Review and submit IRB submission materials. Customize ICFs to ensure compliance with U.S. IRB requirements. Oversee regulatory documentation, tracking, and reporting processes. Ensure timely filing of safety reports, deviations, and amendments. Ensure Investigator Site Files (ISFs) are completed, up to date, and compliant. Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents. Collaborate with cross-functional teams to ensure regulatory requirements are met. Identify process gaps and support the improvement of departmental processes.