I’m working toward a better future for patients. And I do it
Meet Stuti, a Senior Regulatory Affairs Consultant guiding clinical trials through development and approval
"Parexel values diversity and fosters an environment where all employees are respected and included. Individual differences in backgrounds, perspectives, and experiences are recognized and celebrated, creating a sense of respect for each team member."
Discover Stuti's day-to-day work, which involves collaboration between cross-disciplinary teams, managing projects that push the boundaries in healthcare, and providing expert regulatory advice across all phases of development. From joining Parexel from working at a startup, Stuti shares her passion for making a tangible difference in patient care and what it takes to succeed in her role.
Let’s get to know Stuti and her role a little more!
What does a day in the life of your role look like?
In my day to day, I work with cross disciplinary teams of subject matter experts to lead the project and support our Regulatory Consulting work. As a Senior Regulatory consultant, I have my own portfolio of clients. I lead a team of technical experts and writers to support companies who are seeking US development and approval.
My day to day involves managing the project internally as well as externally for our clients. We have a global, multidisciplinary team of Regulatory Consultant subject matter experts in CMC, nonclinical, clinical pharmacology, and clinical and also collaborate closely with experts in other Parexel functional groups, such as epidemiology, biostatistics, and the physicians in our clinical trials group.
Our clients seek our regulatory advice on a wide range of matters, across all phases of development. For example: Sometimes, there will be longer term projects, such as advising on and preparing for an IND or NDA submission. Then there may be quick turn-around projects, such as when a company wants input on a specific issue or wants advice on FDA meeting preparation.
One of the exciting aspects of the Senior Consultant role is that I get to work with cross disciplinary team of experts and get to learn something new every day. Since we support the full range of product types, the companies we work with are varied and can scale from large pharma to start-ups pursuing their first commercial drug development. Therefore, one gets to influence a product’s development plan even from the earliest stages and lead a team of experts.
What part of your job are you passionate about and would like to share?
I love that in my day to day, I get to interact with cross disciplinary team of experts and get to learn something new every day. I get to work with startups as well as big pharma companies and get to interact with the team of experts in different disciplines and make strategic decisions.
What skills are needed to be successful within your team?
As a Senior Regulatory Consultant, you need to be a diplomat, while still being objective about the company’s available data, science, and regulations. You need to have great communication skills as well as should be a team player. Every client has its own processes, every assignment its own issues, so you must be agile and able to take new ideas on board quickly that may challenge your previous thinking. You have to be ready to learn and accept others weakness since you will be leading a team of technical experts and work with a positive attitude for the best outcome.
How do you work With Heart™ and what does it mean to you?
It’s about showing up in a way that lifts and supports the people around you. It’s being authentic and holding space for others to do the same. Simply put, it’s about showing up with a positive attitude everyday.
What makes Parexel unique?
What I love and have experienced at Parexel is the way I always feel supported. I find that my colleagues are always supportive and help me, and each other, out in every step of the process.
How has Parexel supported your career growth?
I joined Parexel from a startup company, where I had been for 3 years. I began my career by working in Quality and Regulatory roles and before I joined Parexel I had expertise and knowledge with drug and device submissions. My previous role as a regulatory manager, provided tremendous insights into drug development for a particular class of drugs and devices, which sparked my interest in learning the process and considerations for a wide range of products and drug and device classes. I wanted to develop my project management skills. I believed that regulatory consulting would be a good way for me to apply both my knowledge and add to my experience. That is what led me join the Regulatory Consulting team at Parexel!
Has there been a project you've worked on that has been rewarding?
Every client has its own processes, every assignment its own issues, but I recently ran into a challenge where the client's IND timeline and the expectation for submission was not as expected by our internal team. In such situation, the entire team of Parexel experts came together to help and meet the IND submission timeline for the client. It was a lot of hard work, but it was a great learning opportunity and very rewarding.
How do you value Parexel keeping the patient at the heart of everything we do?
I value Parexel’s energy in keeping the patient at the heart, it provides an overall purpose to why we do this work each day. I think that patient-first is really a principle that Parexel follows. Parexel's focus on patient-centric clinical trials makes me think about my impact regularly. Behind the numbers is a patient that went through the process of a clinical trial.
How does your team support flexibility and work-life balance?
My Line Manager and the management team at Parexel understand the importance of work-life balance and open communication channels are maintained within the team. This allows for discussion on workload, priorities, and timelines. By keeping an open line of communication, we can address potential concerns and ensure work-life balance is maintained.
How do you feel empowered and accountable?
Employees at Parexel are empowered to make decisions and take ownership of their work. They are given the autonomy to explore innovative approaches and contribute their expertise to projects. Each employee has a clear understanding of their roles and responsibilities, which promotes accountability.
How do you see our core value "Respect" in action within the company and your team?
Parexel values diversity and fosters an environment where all employees are respected and included. Individual differences in backgrounds, perspectives, and experiences are recognized and celebrated, creating a sense of respect for each team member.
How does your team take quality seriously?
Parexel invests in training and developing its employees to foster a culture of quality. Teams receive specialized training in their respective areas, ensuring they have the necessary skills and expertise to deliver high-quality work.
Are there any habits, behaviors, or beliefs you find to be helpful in your everyday personal and work activities?
- Effective communication
- Time management
- Positive attitude
- Resilience and adaptability
What do you enjoy outside of work?
In my free time, I enjoy spending time with my family, going to different hikes and being outdoors, I also love traveling and dancing especially practicing my Indian classical dances. I also love blogging and have my blog where I share my interests related to fashion and travel with my social media audience.
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