[Personal Statement: Graduate Studies in Regulatory Affairs]

The focus of modern business and health care is growing more global each day. At the same time, growth has come hand in hand with increased regulation. In my current position as an Export Compliance Manager in the biotech field, I feel it is especially critical for me to gain a more profound knowledge of the regulations and regulatory agencies that have become so important in the industry. As a candidate for graduate study in Regulatory Affairs at Northwestern University, I am eager to expand my knowledge, and excited about the mission of making people healthier and happier using these emerging technologies.

Over the past several years, my career goals have aimed squarely in the pharmaceutical field. Most recently, I have completed certificate courses in Biotechnology Business & Marketing, and Bioscience Essentials for Industry Professionals at Stanford University Extension. These classes were created to help professionals, both within and outside the biotechnology sector, to rapidly develop the knowledge and skills necessary to understand and work effectively in the global biotech industry. Because my university degree from Italy is in Marketing, I felt it was crucial for me to gain a solid understanding of the scientific foundations underlying the industry's activities. Encouragingly, I have been able to apply the knowledge I gained in these courses in my current position at Genex Laboratories.

My experience working as an Export Compliance Manager at Genex has vastly increased my familiarity with the pharmaceutical industry and allowed me to challenge my academic education in a real-world, professional environment. My duties include coordination between manufacturing facilities and integration of information from worldwide subsidiaries. This comprises such things as product labeling, product codes, export restrictions, and new compliance under the China RoHS, REACH & the WEEE European Program. My position is therefore geared towards a global environment in which products are becoming more and more regulated. I rely on my fluency in several languages to interact, communicate and coordinate, not only with company branches worldwide, but also local and international regulatory agencies.

I believe that the program at Northwestern University will help me advance my career with a broader regulatory foundation. I aim to play a critical role within my organization, providing operational and tactical support to expedite the development and delivery of safe and effective healthcare products to people around the world. As a highly motivated professional, I plan to bring to the classroom environment my perseverance, discipline, and dedication. I enjoy the challenge of complex and often demanding work environments and I am confident that this graduate course will provide me with a firm foundation for future work as a Global Regulatory Affairs Coordinator. But it is my sincere interest in helping others that has driven me to the health industry, and my curiosity and affinity for science that truly fuels my passion for the field.

My time at Genex has also cemented my commitment to a “safety comes first” development environment. Regulatory Affairs is a crucial department in the approval and compliance process and, ultimately, in a product’s success. It therefore has a profound impact both on the company’s bottom line and for patients’ health. I believe that a deeper understanding and interaction with regulators will be tremendously important for me to continue providing patients with safe products that comply or exceed worldwide standards.

In the ever-changing field of biotech, an up-to-date education and continually expanding knowledge base is necessary in order to coordinate international projects with diverse companies, cultures and regulatory agencies. Of all the graduate studies in the field of Regulatory Affairs, only Northwestern meets my current needs in terms of flexibility, duration and reputation. The ability to apply new information and adapt to greater change is quickly becoming essential for anyone working in the biotech field. I am therefore certain that graduate study at Northwestern University will be an invaluable extension of my academic pursuits, and a major step towards achieving my career objectives.

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What's good about this essay?

• It explains how past experiences have shaped the applicant's career goals.
• It demonstrates knowledge of the field and all his applicable experience.
• It is tailored to a specific university (Northwestern) and specific program (Regulatory Affairs).
• It brings these things together to show a single, inevitable next step (grad school in regulatory affairs)
• It is well written and concise.