I'm working toward a better future for patients. And I do it
Meet Sinan, VP Technical of Regulatory Strategy
"I find great satisfaction in guiding clients who have exceptionally innovative products or prospective trial designs. This allows me to expand my technical knowledge and forces me to deeply contemplate how we can effectively present and justify these innovations to regulatory authorities."
Meet Sinan, whose career journey is a testament to the growth and opportunities at Parexel. Sinan enjoys and appreciates the direct influence his work has on ensuring patient safety and product efficacy. This ongoing sense of motivation and pride continues to inspire him in his professional endeavors.
Let Sinan's story inspire you to explore how far your expertise and enthusiasm can take you at Parexel.
Please introduce yourself and your role at Parexel.
I joined Parexel in the Regulatory group in 2022 as Vice President (VP Technical). Prior to that, I worked for more than a decade at the Danish Medicines Agency. I joined the Regulatory team at Parexel because I saw it as the perfect opportunity to utilize my knowledge and further enhance my experience in the field of regulatory consulting. I strongly believe that this role allows me to apply my expertise and contribute effectively to the team.
Could you tell us a little about your career to date?
More than a decade ago, I began my regulatory career as a Senior Medical Officer at the Pharmacoviligance and Medical Devices department at the Danish Medicines Agency, but moved quickly to the Licensing Division, where I joined the Cancer Team. I was the lead clinical assessor on countless oncology products, where several are standard of care now. Shortly after joining the Cancer Team, I was nominated as a Member of the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) and also CHMP’s Oncology Working Party (ONCWP). I became the Chair of ONCWP later, where I was responsible for driving the EMA’s guidelines and policies in oncology. As a member of ONCWP and later a member of CHMP, I had monthly meetings with the FDA’s Oncology Center of Excellence (OCE) to discuss ongoing procedures, guidelines, designations, scientific advice, etc. This gave me an in-depth understanding of the guidelines, policies, and decisions at the OCE. I was nominated as a Member of CHMP in 2015, and shortly thereafter I was appointed chief medical officer at the Danish Medicines Agency. Based on my experience, I can provide a solid understanding of the regulatory landscape, the regulatory requirements, but also the clinical requirements.
What does your role as VP Technical look like?
I provide strategic, regulatory, and clinical advice about the development of products, pre-IND, IND, NDA, BLA, MAA, ODD, PRIME, Fast track, Breakthrough designation, high-stake meetings, etc. Reviewing and providing gap analysis on important documents before submission to the FDA and EMA, and preparing due diligence assessment reports for different clients. I interact a lot with new and existing clients.
What does a typical day of a VP Technical consists of?
It can vary a lot! At Parexel, the nature of our work in the Regulatory team is highly diverse and tailored to the specific needs of our clients. The range of projects and development programs we handle varies based on the client and the type of products involved. For instance, we might assist a prominent pharmaceutical company in exploring potential expanded uses for their existing products. On the other hand, we may provide comprehensive guidance and support for a startup biotech company in their new Investigational New Drug (IND) submission, as they may lack in-house regulatory expertise. The dynamic nature of these assignments is what makes our work at Parexel incredibly interesting and engaging.
What factors are crucial to consider for the VP Technical role?
Working as a VP Technical is like working in the emergency room (ER). You see many different things, and you need to adapt quickly from one project to another and from client to client. It is crucial to have the ability to adapt quickly and embrace new ideas that may challenge our existing beliefs.
What aspect of your job do you feel most passionate about?
I find great satisfaction in guiding clients who have exceptionally innovative products or prospective trial designs. This allows me to expand my technical knowledge and forces me to deeply contemplate how we can effectively present and justify these innovations to regulatory authorities.
What are ‘must-have’ skills needed for the VP Technical’s role?
VP Techs are expected to have the highest technical skills, but this alone doesn’t make one a great VP Tech. More importantly, you need to have that “helicopter view” that allows you to have a vision for a given product, and how to get it to the market in a timely manner, for the benefit of patients and society in general.
How do you work "With Heart" and what does it mean to you?
You must have a passion for science, but always with the patients in the center of everything you do. At the end of the day, it is the patient that matters.
What do you enjoy outside of work?
I love to read, and it has been a passion since childhood. I particularly enjoy the classics. More importantly, I enjoy the long “walks-and-talks” with my dear wife in the surrounding parks and sea promenade. Finally, I enjoy watching my favorite football club and try to see some of their matches when time allows.
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