Regulatory Specialist

JOB SUMMARY

We are seeking a meticulous Regulatory Specialist to ensure quality control and compliance of documents within the electronic Trial Master File (eTMF) for clinical studies. You will be responsible for filing site and study-level documents, coordinating timely submissions of Institutional Review Board (IRB) applications, and assisting with site activation readiness. The ideal candidate has a strong understanding of federal regulations and clinical trial compliance, with excellent organizational skills to maintain accurate and complete study documentation.

JOB RESPONSIBILITIES

  • Responsible for performing quality control activities of site and study level documents in the eTMF prior to filing.

  • Responsible for filing site and study level documents in the eTMF according to study plans, Drug Information Association (DIA) TMF Reference Model, and regulatory guidelines.

  • Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, or changes in the informed consent for IRB approved protocols as required by federal regulations and internal policy.

  • Assists PM and CRAs with ensuring sites are ready for activation.

  • Assists CRA with site document collection and tracking throughout the study

  • Develops and maintains a processing and tracking systems for protocol related documentation.

  • Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for clinical trials.

  • Maintains compliance and integrity of study trial master file in paper/electronic formats.

  • Maintains an up-to-date status report and creates summary reports as requested.

  • Performs QCs of the site and study level documents in the eTMF according to the study schedule, including informal reviews before monitoring visits, formal interim reviews, and the final review at end of study.

  • Ensure Code of Federal Regulations guidelines are applied to all proposed human subject research and applicable company SOPs and policies along with state and local regulations regarding are followed.

QUALIFICATION REQUIREMENTS

  • Bachelor’s degree in life sciences, regulatory affairs, or a related field.

  • Minimum of 2-4 years of experience in regulatory affairs or clinical trial management, preferably within a CRO or pharmaceutical setting.

  • Strong understanding of FDA regulations, GCP guidelines, and the Drug Information Association (DIA) TMF Reference Model.

  • Familiarity with Institutional Review Board (IRB) processes and documentation requirements is essential.

  • Excellent attention to detail and organizational skills, with the ability to manage multiple tasks and prioritize effectively.

  • In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

Knowledge, Skills and Abilities:

  • Strong written and verbal communication skills to facilitate collaboration with cross-functional teams and external stakeholders.

  • Ability to identify issues and develop solutions proactively while maintaining compliance with regulatory standards.

  • Familiarity with clinical trial phases and processes, particularly in relation to ophthalmology or relevant therapeutic areas.

  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and other software tools for data management and reporting.

  • Strong analytical skills to assess regulatory documents and ensure compliance with applicable guidelines.

  • Ability to develop and maintain effective tracking systems for protocol-related documentation.

  • Ability to work independently and collaboratively within a team-oriented environment.

  • Strong time management skills, with the capacity to meet deadlines in a fast-paced setting.

  • Proficient in conducting informal reviews and quality checks of documentation to ensure accuracy before submissions.