Regulatory affairs • phoenix az
The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials.This role ensures adherence to local, sta... Show more
Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for the submission of FDA 510(k)s, periodic updates, Canadian applications and registrat... Show more
Are you an experienced, passionate pioneer in technology who wants to work in a collaborative environment? As an experienced Regulatory Reporting Manager you will have the ability to share new idea... Show more
Global Regulatory Labeling Lead.Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, co... Show more
We're hiring a Analyst, Regulatory Affairs to join our Regulatory Affairs team.Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on se... Show more
Grand Canyon State Electric Cooperative Association, Inc.Arizona's electric cooperatives formed Grand Canyon State Electric Cooperative Association Inc.Their primary purpose was to create a nonprof... Show more
Financial Reporting Manager - Regulatory.The Financial Reporting Manager (FRM) will report directly to a Senior Financial Reporting Manager and will be primarily responsible for overseeing the Comp... Show more
External Affairs Graduate Assistant.Grand Canyon University! One of Arizona's leading institutions of higher learning.Located in the Valley of the Sun in the heart of Phoenix, Arizona.GCU is an ins... Show more
Director - Rates & Regulatory Affairs.Level: Experienced Position Type: Full Time Education Level: 4 Year Degree Category: Management.Under the supervision of the Vice President - Rates & Revenues,... Show more
Regulatory Data Product Owner / Basel Regulatory Reporting Consultant.We are looking for a Regulatory Data Consultant with strong experience in the Basel Regulatory Capital framework and regulatory... Show more
Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood!.Clinical Research, Regulatory Associate working from our Phoenix, AZ office location,.Excellent Annual ... Show more
Financial Reporting Manager - Regulatory.The Financial Reporting Manager (FRM) will report directly to a Senior Financial Reporting Manager and will be primarily responsible for overseeing the Comp... Show more
Regulatory Affairs Specialist III.A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.IR... Show more
Assistant Vice President (AVP), Capital & Regulatory Reporting.Discover your opportunity with Mitsubishi UFJ Financial Group (MUFG), one of the world's leading financial groups.Across the globe, we... Show more
Overview The Infosys Healthcare unit is dedicated to transforming the healthcare industry by leveraging cutting-edge AI-driven solutions to simplify complexities and enhance patient experiences.We ... Show more
As a global medtech company, we are driven by our vision of changing the trajectory of lives for a new day and our mission to create ingenious solutions that ignite patient turnarounds.Our relentle... Show more
Roles and responsibilities information is not provided in the raw HTML.Experience required information is not provided in the raw HTML.Skills and certifications information is not provided in the r... Show more
Exercise delegated managerial authority to oversee the overall planning, directing and timely execution of a program, several program segments (each of which is managed through separate subordinate... Show more
The Dean of Student Affairs is responsible for developing, implementing, and delivering a variety of services for students attending programs on campus.The role is under the direct supervision of t... Show more
The average salary range is between $ 130,000 and $ 170,000 year , with the average salary hovering around $ 170,000 year .
The average salary range is between $ 74,006 and $ 170,765 year , with the average salary hovering around $ 105,135 year .
The Regulatory Coordinator is responsible for the coordination, preparation, and maintenance of regulatory documentation and compliance for clinical trials. This role ensures adherence to local, state, and federal regulations, including but not limited to FDA, ICH, and GCP guidelines, and supports the smooth conduct of clinical research studies at the site. They will support clinical research teams by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. S/he will be responsible maintaining accurate and up-to-date regulatory files. S/he will serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director of Research Services. Prepare, review, and submit regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations. Reviews informed consents for institutional language and work with legal and sponsors to ensure CTA language is consistent with consent. Maintain accurate and up-to-date regulatory binders, including signed investigator agreements, CVs, and medical licenses. Develop and maintain electronic regulatory files in compliance with institutional and sponsor requirements. Track protocol approvals, renewals, and amendments to ensure study compliance. Monitor study compliance with federal regulations (FDA, OHRP) and guidelines (ICH, GCP). Maintain site readiness for internal and external audits and inspections, including preparing regulatory files and ensuring proper documentation. Assist in preparing responses to audit findings and implementing corrective actions. Ensure prompt and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and protocol deviations. Provides study updates, deviations, and SAE reports to Director of Research Services.
Bachelor's degree required. Minimum of 2 years of experience in regulatory coordination within clinical research, preferably in oncology. Knowledge of FDA regulations, ICH guidelines, and GCP standards. Experience with IRB submissions, protocol amendments, and regulatory document management. Experience working with multiple central IRBs, understanding their submission process and requirements. Proficiency with electronic systems and Microsoft Office Suite. Strong organizational skills, attention to detail, and ability to manage multiple tasks efficiently.
