What do you enjoy most about your regulatory affairs specialist career?

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What do you enjoy most about being a regulatory affairs specialist? What do you dislike the most? Is it challenging? Are there many opportunities to learn and advance?

What keeps you at your job?

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Scott D. Smalley in Sunnyvale, California

87 months ago

Personally, the most rewarding part of Reg Ops (RO) career is striving to satisfy your customers and just about everyone is your customer. I actually enjoy setting up infrastructure for authors, reviewers and approvers to bring order to an environment that is often full of chaos.
On a day to day basis, I really enjoy it when someone comes to me with a report and asks for my help. They may be a genius when it comes to the subject matter but formatting is like another language to some people. I’m able to calmly make eye contact and assure them I can turn it around in a fraction of the time they would require. For me, that’s the best feeling!
As far as the frustrating part, that would have to be when I’m sitting in a planning meeting and someone has gone through a lot of trouble creating a workflow chart that has RO at the very end.
Today publishing has many more requirements than before back in the day when all we had to do was to bate stamp the pages. In today’s environment, we publish on a document level first and then add the documents to the submissions. This requires that documents are started with an approved template with controlled styles to facilitate building TOCs, hyperlinks, references, etc.
RO really needs to be involved before an author thinks of writing a report. They need to develop requirements for templates and styles. They also need to create an electronic environment that resembles the final out put of the documents (submission, CSR). The sooner RO is brought in the better!

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