Abbott Experience:
At Abbott as Sr. Regulatory affairs specialist my work mainly consisted of proving operational and strategic regulatory support. This includes all the relevant regulatory documentation for product filling while ensuring compliance. In addition I managed several strategic projects to improve regulatory productivity and compliance. Through this initiative I was able to achieve a 40% improvement in regulatory compliance throughout LA countries.
When I joined Abbott I started working on a Plant decommissioning project and I was responsible for providing regulatory input for the countries that were taking products from that site. To do so I developed a matrix to contemplate all the countries regulation and execute the project in compliance and under the deadlines established by the business.
After successfully completing that assignment I joined the LA team, which was in a big need of structure and organization. The LA team was very small for the amount of countries that it includes. Joining the LA team was a great opportunity and a great learning experience because in a short amount of time I was able to understand the different countries regulations and be up and running to successfully comply with the business goals assuring approvals. Some of the tasks and roles I accomplished at Abbott are:
I developed and executed regulatory assessments to ensure successful registration and approval of nutritional products in LA. Establishing cross-functional communication.
Acted as the liaison between cross-functional groups to assist in key regulatory strategies
In conjunction with the project management team I defined regulatory strategies for registration of products to meet the year launches goal advising on international regulatory requirements..
I assured compliance of product formulation, labeling and promotional materials.
Maintained awareness of Regulatory legislation and assess the impact on business and Abbott product development programs.