Gina Ross

Managing Director, Regulatory Submissions and Administrative Operations

Gina Ross is Managing Director, Regulatory Submissions and Administrative Operations, for the Regulatory Sciences group of Cardinal Health Specialty Solutions.

Role responsibilities

Ross is responsible for the overall business development, strategic, managerial and operational aspects of a diverse team of regulatory document specialists, regulatory submission specialists, project managers and registration/licensing specialists. Previously, as Director of Regulatory Submissions Operations and Publishing, Ross was responsible for the introduction, creation and implementation of the regulatory publishing department. This group has more than 30 associates providing regulatory publishing services through a wide-range of diverse workflows and processes, including outsourced publishing for large pharmaceutical companies. 

Professional experience

Ross has more than 17 years of thought leadership and management experience in the field of regulatory operations and has presented on this topic in webinars and at Drug Information Association conferences. Prior to joining Cardinal Health in 1998, she served as a controller for the Mayer Hoffman McCann public accounting firm.

Professional affiliations

Ross serves as treasurer for the Implementation of Regulatory Information Submission Standards (IRISS) forum, which is a global, open, multidisciplinary nonprofit organization dedicated to the implementation of regulatory submission standards.

Education

She received a bachelor’s degree in business administration, with an emphasis in accounting, from Rockhurst College.

Areas of Expertise


electronic Common Technical Document (eCTD) format

Regulatory submission operations

Electronic document management

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