When I started at Merial, it was by chance ... I said to myself, "OK, 6 months, I’ll try it.”Corinne
What's your current role at Merial?
In March 2016 I started a new position in R&D as R&D Project Leader to lead project teams for the development of vaccines. I'm very excited about the changes ahead with my new role!
I spent my first 15 years at Merial working in Regulatory Affairs (RA), most recently as the Director of Biological New Projects. RA was a great place to work because it encompasses so many aspects of the business, and in my new R&D position I'll still work very closely with the RA team.
You trained as a veterinarian—did you ever practice? How did your career evolve toward Regulatory Affairs?
Yes, I did two years of practice. One year in the countryside where I worked mostly with pets, and a bit with livestock and horses. When I went back to the city, it was only pets.
When I started at Merial (in 2001) in Lyon, France, it was initially by chance I would say, just a temporary position that I found appropriate to balance with my very new “career” as mother! It was a temporary project manager position and I said to myself, "OK, 6 months, I’ll try it.” It seemed interesting because it was about rabies, foot-and-mouth disease, and about vaccines, things that had interested me for a long time. I worked on an international regulatory dossier for Merial’s wildlife rabies vaccine, and I discovered so many interesting things at Merial, that when I had the opportunity to stay permanently with a position on the International Regulatory Affairs team, I took it.
It seemed like you never stop learning, each time you talk with somebody you learn something you didn’t know before."Corinne
Why is that? What kinds of things excited you about working at Merial?
Well, there were a range of activities to discover, from R&D, production, the clinical work, etc. I interacted with people from very varied backgrounds. Also, it was very multicultural—I could talk sometimes in the morning with Asia, and then in the afternoon with Latin America, so for me that was very exciting, very different from what I’d previously experienced. It was so varied, with so many opportunities. It seemed like you never stop learning, each time you talk with somebody you learn something you didn’t know before.
Can you give an overview of the function of Regulatory Affairs?
In my most recent role in Biological New Projects, we supported project teams that develop new vaccines, by giving them advice on the regulatory requirements, constraints, what we have to follow and comply with. I'd be writing the dossier—the document that is ultimately submitted to regulatory authorities to approve a product—all along the product development process. The dossier covers most aspects of the vaccine: manufacturing, the controls, the clinical features, the efficacy and safety of the product, etc.
Once the product development is done, the dossier is submitted to the regulatory authorities, and we go through a phase of questions and answers. Once the regulatory authorities grant marketing authorization, we can launch and start selling the product.
After product launch, Regulatory Affairs (RA) teams continue to support the product in the field and remain the contact for interactions with regulatory authorities on the content and implementation of regulations.
It's a lot of contact, phone calls, face-to-face meetings. I'm not very often in my office behind a computer writing the dossier!"Corinne
How does the Regulatory Affairs group interact with other functions in the company?
We have a lot of contact with almost all the functions—R&D, clinical, marketing, production, etc. We have a lot of meetings where we discuss strategy and debate the data. So it's a lot of contact, phone calls, face-to-face meetings. I'm not very often in my office behind a computer writing the dossier! I spent a lot of time talking about it, and then try to find some time to write. And while I'm responsible for leading the writing of the dossier, of course it's a collective work—all the functions validate what has been written.
What kind of background, training, or skills are necessary for somebody interested in getting into Regulatory Affairs at a company like Merial?
Well, it depends on the role. But for a manager, you need to have a technical understanding of the product, that’s definitely necessary so you can explain to the authorities what the product is about as well as understand details discussed by the product team. A veterinary background of course is good training, but we also welcome pharmacists, biological or chemical university degrees, etc. I also did a post-professional diploma program in regulatory affairs—it’s not something mandatory, but it really helped round out my background.
But it’s not only the training—it’s also the ability to negotiate, to explain things with patience, with compromise, to develop trust with your colleagues. Interpersonal skills are really necessary in this kind of position.
What have you liked most about your job, what’s been most rewarding?
The thing I'm most proud of is the relationships I've built with my colleagues."Corinne
What I enjoy the most is the teamwork—it’s really rewarding because it's the whole team coming together toward the objective of getting marketing authorization. It's always a team effort, which I really enjoy. Probably the thing I'm most proud of is the relationships I've built with my colleagues.
What about the biggest challenges of working in Regulatory Affairs?
The biggest challenge when we develop a vaccine is anticipating the evolution of the regulations. Because when you start five years in advance, planning these kinds of clinical trials, those analytics—maybe five years later when you finish the work, the legislation will have changed and require something else.
You've been at Merial almost 15 years—how would you describe the company’s culture?
To me there is a lot of focus on the quality of the product we want to develop, on the service we want for the customer. It's customer-oriented, I would say. We also have a good work spirit. We are team players. And you feel you can speak up, you can give constructive criticism, and so on—that's really something that I appreciate. I hope to be here for the next 15 years of my career!