The Certara Blog

Author: Rob Connelly

Rob Connelly brings a wealth of experience in regulatory operations and electronic publishing to Synchrogenix, a Certara company, having developed a variety of internal systems and overseen the submission of marketing applications to several countries during his nearly 20 years. Mr. Connelly successfully scaled and presided over a growing regulatory operations group at ViroPharma, and fulfilled a variety of roles in regulatory operations at GlaxoSmithKline. His expertise includes evaluating and working with dozens of publishing, tracking and document management systems, and customizing those solutions to function efficiently within the parameters set forth by individual organizations with unique environments. In his role as Product Manager for Global Submit Electronic Submissions Software, Mr. Connelly applies the insights gleaned working from a regulatory vantage point to developing software tools that result in greater quality and streamlined processes for the life science industry. Mr. Connelly received both his Bachelor of Science (BS) in Finance and a Masters of Business Administration (MBA) from La Salle University in Philadelphia, PA.

Recent Posts

Best Practices for a Successful eCTD Submission

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. In this blog post, […]

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Things About eCTD You May Not Have Known

In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format. While a lot of us have been working in the eCTD format for many years, new start-up companies focusing on rare diseases and new technologies to treat patients are […]

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