Associate Spotlight – Ludjane Carvalho
Learn more about Ludjane Carvalho, Associate Director, and her experiences as part of the Regulatory Affairs Team
Q. Can you tell us a little about your role at PDI?
Carvalho: I am an Associate Director in Regulatory Affairs and I am responsible for ensuring that our Drug Products, Medical Devices, and Cosmetics are in compliance with regulatory requirements, from FDA regulations to state legislation. I support the Interventional Care Core Team by providing Regulatory Strategies to our new product development projects, which lays a clear pathway to bring new products to market. In addition, I support product improvement and cost saving projects by preparing different types of submissions to the FDA ensuring changes to our marketed products are approved.
Q. Are there any unique / exciting projects you have been able to work on while at PDI?
Carvalho: An important role of Regulatory Affairs is to monitor and assess the impact of new regulations and requirements from regulatory agencies. I have worked on a project to implement a Regulatory Intelligence program at PDI. That includes a new procedure with defined roles, a template that can be used to capture any gaps, a database to store new regulations and guidance documents, as well as a tracker to log them in. This new process and tools are now used across several functions, so SMEs can assess the impact of different requirements under their area of expertise. The regulations are dynamic and constantly evolving, and monitoring or influencing them as they evolve is important to PDI.
Q. What impact do you feel your function has had on the industry, particularly during COVID?
Carvalho: Supply shortages were a key challenge, everywhere, during the COVID Pandemic. To ensure business continuity, the Regulatory team, in collaboration with other functions, worked on several high priority projects to approve new raw material suppliers for our products. Because many of our products are indicated to prevent infectious disease, it was critical to ensure their availability especially during the pandemic.
Q. Can you provide some insights on your team dynamics / working relationships with colleagues?
Carvalho: The Regulatory team is constantly collaborating with other functions so we have the data and information we need to maintain our current product licenses and to register new products, among other activities. Regulatory has representation in all Core Teams to provide regulatory guidance and support their projects. I have built a great relationship with the IC Core Team members and really enjoy working with all of them.
I also have an amazing team reporting to me. They are SMEs in their product categories, but have also demonstrated the flexibility to step in and help with other projects to support the business needs. I encourage cross training within my team so we are always expanding our knowledge by learning from each other, which supports development. The broader Regulatory team also works together to ensure business goals are met, and while EPA and FDA have different regulations, there are many opportunities for interaction and cross training between team members.
Q. How long have you been with PDI and why have you decided to stay with the company?
Carvalho: I have been with PDI for 3 and a half years. Some of the reasons I have decided to stay with PDI are the company mission, culture and product portfolio. I am very proud to be part of a company whose mission is to save lives and is always trying to “Be the Difference” by helping the local community. PDI has a great culture that really values the people and promotes professional growth. PDI also has a uniquely broad portfolio, which includes Medical Devices, Drugs, Cosmetics, Surface Disinfectants and Household products. This diversity allows me to gain experience working across multiple product classifications. I would say though that the main reason is the people. I have the privilege to work every day with an amazing group of talented and dedicated people.
Q. How has the company evolved since you joined?
Carvalho: PDI has a very strong presence in the Environmental Care area. I have seen continued support from management for projects to expand the Interventional Care business which will bring new solutions to protect patients against infectious diseases. The company has invested in resources to become a key player and a trusted advisor in the skin antiseptic area.