I have been in regulatory affairs in the pharmaceutical industry for over 19 years and often heard of PDA in passing. In 2013, I moved into the biologics space at a manufacturing site for bulk biologic manufacturing and aseptic filling. At this time, I started truly leveraging PDA’s technical reports.
Then, in 2016, a colleague of mine asked if I would be interested in providing feedback with PDA on a U.S. FDA draft guidance. This spurred another colleague to ask about my interest in working on the ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry initiative with PDA. I have been hooked ever since.
Remember to use the time as a learning experience. You will learn at the same time as you work with your peers.
One of the best pieces of advice I have ever received—and it is almost always true in work and in life—is to “sleep on it.” It is so true that things always look better with some rest and some time to think through the facets of an issue.
Right now, I am reading some great leadership books including Brené Brown’s Dare to Lead. Brown also
delivered a great TED Talk on vulnerability and has a new Netflix special.