Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet Philip Simonson, PhD, Senior Vice President, CMC Regulatory Sciences
What do you do at ProPharma? How does your role support improving the health and safety of patients?
In my role as the Senior Vice President, CMC Regulatory Sciences, I am privileged to lead and manage a team of seasoned regulatory scientists with decades of collective experience and expertise in the industry. Our team brings complimentary skills together, and we support a wide range of product types including both small and large molecules, advanced therapeutics (including cell & gene therapy), vaccines, blood products, and combination products. We are focused on supporting clients in all phases of drug development from early discovery through product registration and post approval. Our primary mission is to guide clients through the many and varied technical & regulatory requirements to bring important new medicines to patients around the world. We achieve this by building sound CMC regulatory strategies, providing thorough gap assessments and remediation plans, developing effective health authority communication plans, and authoring clear and concise regulatory submission documents.
What is one lesson you’ve learned in this industry that has most helped you?
One of the most valuable lessons I've learned is the importance of having a balanced perspective. In other words, never getting too high or too low and evaluating and assessing all available information with both a subjective and objective mindset. This is particularly important in regulatory sciences, and it has allowed me to form clear prioritization of work and effort for me, as well as the teams and clients I have led. It has also enabled me to deal with adversity and pressure with a calm demeanor while working toward successful solutions and outcomes.
What's your number one goal / focus right now?
Since I am relatively new to ProPharma, my priority is to become fully integrated into the broader ProPharma community. I am doing this by engaging and networking with teams across a variety of internal disciplines including Regulatory Sciences, Quality & Compliance, Business Development, Marketing and R&D Technology. My objective is to leverage these relationships to expand on the tremendous successes we have had in the CMC Regulatory Sciences space already, and to continue to broaden the scope of our service offerings and the capabilities we can provide to our clients.
Tell us a little bit about yourself outside of work.
Outside of work, I literally like to be "outside!" I recently relocated to St Petersburg, Florida, where I try to enjoy as much time as possible on the sand, the water, or the golf course. My wife Sue and I have 2 grown children, and last year we welcomed our first granddaughter to the family. We are also very fond of Yorkshire Terriers, and our 7-year-old yorkie gives us another excuse to be outside.
What is unique about our culture at ProPharma?
What I have found to be unique is that there is a true "Culture of Excellence" at ProPharma! This is evident from both top to bottom and from side to side as I continue to meet so many talented colleagues who are committed to being the best. It is an engaging team of experienced professionals who are experts at what they do and are fully committed to delivering for our clients. The culture is also very friendly, and I was welcomed with open arms!
