Stanford University · 3 days ago

Regulatory Specialist

Stanford, CA

Full-time

Remote

Mid, Senior Level

$87K/yr - $126K/yr

5+ years exp

Maximize your interview chances

EducationHigher Education

Growth Opportunities

Insider Connection @Stanford University

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

Responsibilities

Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.

Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development.

Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.

Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.

Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.

Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.

May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.

May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.

May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Protocol/IND writingRegulatory affairsFDA regulationsIRB review processClinical PracticeBMT-CT disease focusClinical research managementTraining/education developmentProject managementMS Office productsDatabase applicationsCustomer service focusSafety reporting procedures