Michelle Jon Nauerth

About Michelle Jon Nauerth

Regulatory affairs associate assuming primary or secondary responsibility for assigned clinical research projects by providing the project team with regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies). Identifies and interprets guidelines, regulations, and other pertinent information issued by applicable regulatory agencies. Reviews protocols, consent forms, and related documents for various clinical research projects to ensure compliance with regulations. Develops and submits clinical trial applications to competent authorities.Proficient in identifying and evaluating fundamental regulatory issues within clinical projects, interpreting data from complex data sets, and making sound business decisions. Skilled in verifying the implementation of effective solutions to address identified issues. Dedicated to ensuring that all project deliverables align with client expectations regarding time, quality, and cost. Collaborative approach to working with other functional leads to meet and exceed client needs and expectations.

Experience

1. Global Regulatory Affairs Associate

   IQVIA

   Aug 2021 — Present · Raleigh-Durham-Chapel Hill, NC, US

   Manage, write, and oversee the preparation, review, and submission of Clinical Trial Applications (CTAs) to global regulatory authorities such as Health Canada.• Provide regulatory advice and guidance to multidisciplinary teams on the regulatory requirements to support drugs, biologics, and combination product development.• Serve as the regulatory lead to external clients and internal stakeholders.• Develop project timelines; develop strategic goals with staff; and provide guidance and assistance.• Maintain effective communications with client and project team throughout the study.• Direct the development and incorporation of the Regulatory Management Plan (RMP) to assure compliance within competent authority regulations and ICH/GCP guidelines.• Assist Regulatory Affairs Manager by assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency (ies).• Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations. • Review protocols, ICFs, reports, scientific documents, publications, and related papers, etc. as appropriate for clinical research projects to ensure compliance with regulations.• Serve as a member of groups, teams, and/or committee related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities as appropriate.• Research FDA/EMU website for new guidance

Education

• The Ohio State University

  Ph.D., Biochemistry

  2006 — 2011

• Adelphi University

  Chemistry and Mathematics