Laurie Henricks

Director, Regulatory Submission Operations – Publishing

Laurie Henricks is Director, Regulatory Submission Operations – Publishing for Cardinal Health Regulatory Sciences.

Role responsibilities

Henricks is responsible for oversight of all regulatory submission publishing services, which support global submissions and large outsourced publishing projects for small virtual to large pharmaceutical and biotechnology companies.

Professional experience

Henricks has more than 29 years of experience in the pharmaceutical industry, focusing in the areas of compilation and publishing of pre- and post-approval global regulatory submissions. Henricks has extensive experience managing global teams responsible for the compilation and publishing of paper and electronic New Drug Applications (NDAs), Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs) and Investigational New Drug (IND) applications. She also specializes in electronic Common Technical Document (eCTD) format compliance, Non-eCTD Electronic Submissions (NeES) and regulatory affairs (authoring, agency meetings, submission management and lifecycle maintenance and regulatory consultation).
Henricks also has experience in the implementation of dossier style standards; training on electronic submission, design and implementation of document management and publishing systems; development of submission and publishing processes; design and implementation of submission standards and publishing technologies.
Prior to joining Cardinal Health, Henricks was a Senior Director, Global Regulatory Operations, for 16 years with Quintiles. Before Quintiles, she spent 14 years with Hoechst Marion Roussel Inc. (formerly Marion Merrell Dow and Marion Laboratories), in various positions within publishing, regulatory affairs and regulatory operations.

Areas of Expertise

Regulatory submission operations

electronic Common Technical Document (eCTD) format

Document management


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