Provide regulatory advice, lead, execute and deliver regulatory project work
Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.
Assist in preparing for sponsor monitoring visits and follow up requirements.
Develop and implement regulatory strategies to support sites activities
Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
Coordinates preparation and review of key site essential records.
Track essential records and timelines
Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
Actively work towards KPIs to help ensure departmental success
Supports creation and maintenance of study Delegation of Authority (DOA) logs
Support regulatory activities throughout the duration of the study lifecycle; collaborating with clinical operations teams to ensure regulatory compliance

Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements.
Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.

Senior Specialist, Regulatory Operations

Key skills