Profile

Username

renya-maku

First Name

Renya

Last Name

Maku

Title

Regulatory Analyst

Location

St. Petersburg, FL, USA

Professional Bio/Service Description

With a diverse background in healthcare, retail and customer service, federal grant management, and research and regulatory operations, I’ve spent years helping clinical research teams transform complexity into clarity ensuring compliance while strengthening collaboration. I bring the kind of systems thinking and pattern recognition that makes oversight smoother, data cleaner, and teams more confident. I’m a progressive thinker who sees patterns and draws insights from things others might not notice which helps me see inefficiencies and help create systems that people can adhere to in order to solve for them.I’m a regulatory analyst with a Master of Public Health in epidemiology and biostatistics. I have firsthand experience with IRB submissions, supporting academic research teams on industry sponsored projects, federally sponsored projects, and investigator-led trials through every phase of a study from start up to close out. The most rewarding part of my job is knowing that I am contributing to the advancement of healthcare on a large scale and bringing innovative care to patients.My areas of expertise include:IRB submissions (initial, amendment, continuing review, RNI/PRI reporting), protocol and informed consent form writing and revisions, quality assurance and improvement, audits, and FDA inspection preparedness, regulatory document preparation, credentialing, and routine regulatory maintenance, SOP support and staff training, clinical trial activation and site readiness coordination, and collaborating to streamline the complex study start-up process. I’m currently pursuing the SOCRA CCRP certification and the RAPS RAC-Drugs certification both to strengthen my knowledge and current role, and have a detailed understanding of the FDA submission process for IND submissions, NDA submissions and review, and post-marketing life cycle management.

LinkedIn URL

http://www.linkedin.com/in/renyamitchell

Languages

English

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