Certified Regulatory Specialist III Position Available In Orange, Florida

Job Title:

Research Regulatory Specialist III Location:

REMOTE •Applicants must reside in one of the following states: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia Job Description The Research Regulatory Specialist III provides regulatory support to the research team, assisting investigators with investigational new drug (IND), investigational device exemption (IDE), and biologics applications to the FDA. The role also involves coordinating regulatory activities for multi-site research protocols and acting as a liaison between various stakeholders including the IRB, FDA, study teams, and sponsors. Responsibilities Assist with the submission of research protocols and documents to the FDA for investigational new drug (IND), investigational device exemption (IDE), or biologics applications. Collect and compile data and documents for regulatory filings with the FDA and other authorities. Conduct technical reviews and prepare reports for ongoing IND/IDE applications. Coordinate regulatory processes and submissions for multi-site research projects. Support the orientation of new Research Regulatory Specialists. Prepare and submit new research protocols, amendments, continuing reviews, and other modifications. Ensure completeness and accuracy of documents while meeting submission deadlines. Prepare and submit new and revised informed consent documents, ensuring compliance with IRB requirements. Ensure all regulatory documents comply with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and organizational policies. Monitor review, approval, and clearance activities for each research protocol, maintaining detailed records. Maintain regulatory documents electronically, following standard criteria and current regulations. Essential Skills Bachelor’s degree in healthcare or sciences with at least 4 years of clinical research experience, or an Associate Degree with 5 years clinical research experience Experience in submitting and maintaining regulatory documents, including conflicts of interest documentation.

MUST HAVE ACTIVE CERTIFICATION

through a professional research organization such as SOCRA, ACRP, SRA, or PRIM&R. Candidates without an active certification will not be considered. Must have oncology clinical research experience or other complex therapeutic area Additional Skills & Qualifications Experience in oncology, quality assurance, regulatory compliance, and regulatory submission.