What made you dedicate yourself to science/R&D?

I think it is a fascinating area. The beauty of R&D is that each project is different from the other and you learn from every one of them. R&D allows you to participate in a wide variety of projects at different stages of development allowing a global vision of drug development. Each development is a challenge with its particularities and difficulties.

R&D is a challenging and evolving environment, you never get bored. Also, another rewarding aspect from R&D is that you are in continuous contact with other areas and disciplines, getting alignment from all perspectives (commercial, clinical, market access…) and each of us contributes to the progression of the molecule. 

How your work relates to helping patients in their daily lives?

The Regulatory Strategy Department is involved in several stages of drug development: from early phases of development to approval and lifecycle management. Briefly, we plan the development of the product to obtain regulatory approval in desired markets for the patients to get access to the medicine.

I think that in recent years, regulatory affairs is becoming more patient-centric. Both Pharma companies and Regulatory Authorities tend to involve more patient representatives to understand their needs. There is a tendency to increase the use of patient-reported outcomes in clinical trials.

We contribute to the progression of a particular drug acting as intermediates between the company and the regulatory agencies such as the EMA or the FDA. This process involves working together with the project team and preparing the documents for the agencies in order to get advice from them. All this sounds very technical, but at the end of the day we are all aware that the overall goal for drug development is to improve the health and well-being of patients.