Graduate / University's Master of Science in Bioscience Regulatory Affairs (SoP) [6]

Please advise...Thanks

Continuing my education by pursuing an advanced graduate degree has always been a personal goal. However, after graduating with a B.S. degree in Biology several years ago, I choose to enter the biotechnology-pharmaceutical industry to gain hands-on work experience. The bulk of this experience has been in the production/manufacturing aspect within various biotechnology companies. While employed with these companies, I developed at broad skill-set ranging from understanding current good manufacturing practices (cGMPs) to implementing process changes while maintaining quality assurance compliance. I've also participated in submission of an IND (Investigational New Drug) application for FDA approval. As a graduate school candidate, I endeavor to expand my knowledge base in a more specialized direction by focusing on the regulatory aspects within biotechnology.

Regulatory affairs management has become essential in today's bioscience industry. It encompasses current science practices with legal and business issues. In this exciting time of drug development and clinical trials, there is an urgent demand for "getting it right". I want to focus on improving the safety and efficacy measures as it relates to pharmaceutical products and biotechnology companies. With a regulatory affairs degree, I will be able to ensure the appropriate licensing, marketing and legal compliance of pharmaceutical products. Combining my knowledge of cGMPs and understanding of scientific methodologies, I will be able to interpret clinical trial data, write accessible product information, advise scientists and manufacturers on regulatory requirements, and submit license applications to regulatory authorities.

If accepted to the University's Master of Science in Bioscience Regulatory Affairs, I am confident that with my level of motivation, passion for drug safety, and contribution to industry regulations will make me an asset to the program.