Regulatory Affairs Expertise

horizon award, topra, regulatory affairsDr. Costantino Congiatu, principal regulatory affairs specialist at PPD, received the international Horizon Award at the 2014 Awards for Regulatory Excellence organized by The Organization for Professionals in Regulatory Affairs (TOPRA). Congiatu is based in PPD’s Cambridge office.

Interviewer: Congratulations again, Costantino! Can you share some background on the Horizon Award?

Congiatu: Thank you! The Horizon Award is awarded to professionals with fewer than five years’ experience in regulatory affairs. At the time I was nominated, I had been in the field for roughly 18 months, so you can imagine my excitement when I was told I had been shortlisted! The competition for the TOPRA awards is fierce with nominees from CROs, pharmaceutical companies and consulting firms from all over the globe. I cannot thank Jonathan Bray, my line manager, enough for his consideration and the time he spent on the application. Being recognized for the job I do is great motivation. Receiving an international award for my work was beyond my wildest dreams! There is no doubt it would not have been possible without the opportunities and support I have had at PPD.

Interviewer: Tell us more about your career before joining PPD.

Congiatu: Before joining PPD, I was a scientist and spent a few years between academia and R&D biotech. My background is medicinal chemistry. I used to make new compounds in the lab and, based on their biological activity, tweak their structure to improve their properties. When one of the compounds I worked on was selected for clinical trials, I realized I wanted to see what goes on beyond the lab bench. That’s how I ended up in regulatory affairs.

Interviewer: What does a typical day involve for a principal regulatory affairs specialist?

Congiatu: Well, it’s very interactive. To follow the progress of regulatory application and approval of multinational clinical trials requires constant feedback and interaction with colleagues across the world, the study management team and clients. Mainly we communicate by emails and teleconferences, but regulatory leads occasionally travel abroad to meet clients. Principal regulatory affairs specialists also play a part in business development and provide regulatory expertise and intelligence to help expand PPD’s portfolio. Every day is different.

Interviewer: What do you enjoy the most about working for PPD?

Congiatu: The greatest pleasure of my job is working with colleagues in different countries and time zones. There is a real sense of comradery. Professionally, there is a bottomless pool of intelligence I can dive into and colleagues always ready to help should I ever find myself in shallow waters!

Interviewer: Finally, what advice would you give to someone looking to develop a career in regulatory affairs?

Congiatu: Innate problem-solving skills, a flexible mindset, diplomacy and self-awareness are key attributes of regulatory affairs professionals as we need to find a balance between leading others and gaining consensus. In regulatory affairs, inquisitive minds are actively encouraged. If you tend to question established methods and trends, this could indeed be the right place for you.