Human healthcare is set on a path of a continued development evolving through drug discovery and innovation in medical technology. In spite of new molecules being discovered frequently, most of them fail to convert into a potential treatment. A small percentage of those that do, face the ever-increasing challenges of the healthcare systems, which further makes it difficult for them to reach the patients. In a developed nation with an evolved regulatory landscape like the United States, it is often the competition and reimbursement challenges that delay the potential treatments from entering the health care system, whereas in developing regions like Latin America it is the under-evolved regulations and policies with complex registration requirements.
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The position required interaction with health care providers and distributors and my primary responsibility was to perform product demonstrations to explain the risk/benefit profile and establish a positive brand image of the company’s products. It was quite challenging as it required me to have a scientific understanding of how each product works and develop a clear strategy to ensure that nothing off-label is promoted, which could put the company in a position that is out of compliance. I believe challenges are an important part of a learning experience and irrespective of their outcome they lead to success in one way or another. It was in this endeavor where I was first introduced to Regulatory Affairs. I would frequently collaborate with my colleagues in this group to get approved and valid documents like labeling, patient leaflet, and promotional materials. I was fascinated by how this profession connected with several different cross-functional groups and became the epicenter of the company’s overall success. Over many years it has become a vital part of the healthcare profession being responsible for bringing the life-saving treatment to patients. It is a profession, which is much more than just knowing the regulations; it requires one to understand the product, the disease and …show more content…
It was shortly thereafter that I was promoted to Regulatory Officer. In this role, I was mainly responsible for supporting registration activities in the European Union region, which included preparation of marketing & supplemental applications and responses to the health authority queries, among other regulatory activities. The position was exciting with each day bringing new challenges and learning opportunities. Although the position didn’t fully explore the strategic aspect of regulatory affairs, it challenged me to demonstrate advanced problem solving, communication skills and helped me develop my ability to think critically at different
The position required interaction with health care providers and distributors and my primary responsibility was to perform product demonstrations to explain the risk/benefit profile and establish a positive brand image of the company’s products. It was quite challenging as it required me to have a scientific understanding of how each product works and develop a clear strategy to ensure that nothing off-label is promoted, which could put the company in a position that is out of compliance. I believe challenges are an important part of a learning experience and irrespective of their outcome they lead to success in one way or another. It was in this endeavor where I was first introduced to Regulatory Affairs. I would frequently collaborate with my colleagues in this group to get approved and valid documents like labeling, patient leaflet, and promotional materials. I was fascinated by how this profession connected with several different cross-functional groups and became the epicenter of the company’s overall success. Over many years it has become a vital part of the healthcare profession being responsible for bringing the life-saving treatment to patients. It is a profession, which is much more than just knowing the regulations; it requires one to understand the product, the disease and …show more content…
It was shortly thereafter that I was promoted to Regulatory Officer. In this role, I was mainly responsible for supporting registration activities in the European Union region, which included preparation of marketing & supplemental applications and responses to the health authority queries, among other regulatory activities. The position was exciting with each day bringing new challenges and learning opportunities. Although the position didn’t fully explore the strategic aspect of regulatory affairs, it challenged me to demonstrate advanced problem solving, communication skills and helped me develop my ability to think critically at different