Agota Bodi – Motivated by inclusive and vibrant culture
Passionate about creating solutions and embracing the unexpected.
:quality(90)/)
Curiosity has always been my compass. Whether I am exploring new countries and cultures, hiking through nature’s wonders, learning French, or diving into the art of cooking, I thrive on discovery. At home, I cherish playing chess or watching movies with my husband, as well as the delightful companionship of my playful young cat. In addition, as I pursue my specialization in finance and economics, I find inspiration not only in the knowledge I gain but also in the people around me—those with a passion for innovation, a willingness to step into the unknown, and an unshakeable positivity.
My career journey
My journey began in a pharmaceutical company called Teva, where I gained hands-on experience as a regulatory affairs associate. I have also had the opportunity to work as a Pharmacist in local pharmacies. At my previous workplace, I had the privilege of participating in “Open Day” programs at a manufacturing site. These experiences gave me insights into API manufacturing, Quality Assurance, Pharma Technology, and Packaging. They also deepened my understanding of regulatory affairs, particularly in interpreting guidelines and navigating authorization processes.
In September 2022, I joined Roche as a CTIS (Clinical Trials Information System) Team Specialist, stepping into a world of clinical trial regulation that I find both inspiring and profoundly meaningful. Our work has a clear and vital purpose: to ensure that health authorities and ethical committees can legally authorize investigational medicinal products, ultimately providing patients with safe and effective treatments, preventatives, and diagnostics.
I recently started my rotation as an EU Country Submission lead (EU CSL) for a Phase II/III pediatric study in patients with spinal muscular atrophy (SMA) which I find highly motivating and purposeful.
What I find most fulfilling at Roche is being part of a culture that not only understands the significance of our efforts but also celebrates the collective contributions of everyone involved. While we each may work on a specific part of the process, the combined efforts of many make success possible.
Innovation is another cornerstone of my work. As part of the CTIS team, I have had the chance to explore new ways of working, continuously improve processes, and collaborate with stakeholders like the Clinical Trial Regulatory Management (CTRM) team, EU Country Submission Leads (EU CSLs), and Clinical Research Organization (CRO) colleagues. Together, we ensure that Clinical Trial Applications (CTAs) are submitted in a timely manner, navigating challenges through the CTIS platform, which became mandatory under the new European Clinical Trials Regulation in January 2022.
The dynamic environment of CTIS has also offered me the opportunity to work on something truly groundbreaking: PHIL the BOT, an automation tool that reduces the administrative burden of compiling CTA dossiers in CTIS. Leading discussions from the business side for PHIL has been a privilege, as we continue to evolve the tool in response to regulatory changes and feedback from our submissions. It is not always easy, but tackling these challenges head-on is deeply rewarding.
One of my most memorable moments was attending the CTIS team workshop this year. Meeting colleagues face-to-face from different countries and departments was energizing, and the brainstorming sessions created a safe space to share ideas and inspiration. This inclusive and vibrant culture, where every individual’s contributions are valued, motivates me every day.
Of course, the work comes with its fair share of challenges. From administrative and technical issues to tight timelines and system limitations, the demands are significant. However, every obstacle is an opportunity—to collaborate, innovate, and grow.
I am passionate about creating solutions and embracing the unexpected. For me, each day is a chance to learn, adapt, and make a meaningful impact. Whether I am working on improving PHIL the BOT, navigating the complexities of clinical trial submissions, or brainstorming new ideas with my team, I am driven by a deep sense of purpose. The glass is always half-full in my eyes, and every challenge is just another step toward greater growth and success.
My career tips
:quality(90)/)
Be open to new ideas and collaborate on possible solutions.
Speak up and trust your expertise.
Support and learn from those around you, celebrate achievements.
Address mistakes constructively (this is key in Regulatory) - understand that errors are part of the process, the important part is how you address them.
View each day as a new opportunity to learn.
My RSS high-5!
We had a common goal and industry wide challenge last year - ensuring all our transitional clinical trial applications were submitted in CTIS. This is a huge accomplishment for Roche. Therefore, I would high-five everyone involved to achieve this milestone: Our CTR SMEs Samia Dridi, Valentina Homann, Natalia Lugli, Sandrine Verstratae, the CTIS Team, the CTRM Team, the EU CSL Team, the Study teams, the Country Operations team, Clinical Operations team, PTR & SMG, the CRO Colleagues and every function involved. I am grateful to be part of this journey and to learn from empowering role models.