Highlight on Alumni
Penny Houston, Class of 2011
Where are you currently employed and what are your responsibilities? I currently work for Alcon Laboratories in Fort Worth, Texas. Alcon is now a division of Novartis. At Alcon, Eye Care is the core business model. I am a Global Regulatory Affairs Manager in the Global Clinical and Regulatory Affairs department in R&D. I participate in cross-functional R&D teams. I have responsibility to manage several eye care product lines in many parts of the world, for example, OTC Drugs, dietary supplements, cosmetics, Pharmaceutical, artificial tears, and medical devices. I also participate on clinical affairs sub-teams and help provide regulatory guidance in that area as well. All of these project activities are reflective of courses that were included as part of the JHU curriculum.
How has a Master’s Degree from Johns Hopkins helped you with your career? I am able to be a better leader and give insight and guidance on research and development projects. Prior to taking courses at Hopkins, I only had regulatory affairs experience in the medical devices industry. I also have worked in the laboratory prior to being regulatory affairs however; JHU has allowed me to incorporate the program’s transferable experience into the Pharmaceutical industry where I wanted to grow as a Regulatory Affair professional. Additionally, the AAP program at JHU gave me more tools and resources to accomplish new tasks. For example, I did not have practical experience working with certain criteria in the Pharma arena but I was able to join in at Alcon and hit the ground running because in the JHU program, we had completed theoretical exercises where I learned how to implement FDA and international rules and guidance for global product submissions. The Hopkins program gave me an advantage where I was able to execute certain projects in my every-day activities; such as being part of a team who creates CTDs and Global Dossiers for domestic and international product approvals.
What was your most memorable experience from this program? There was a team exercise in my project management class where our team had to develop a molecule and take this drug to market. Since this was an online course, my teammates were located all over the world, one as far as China. The best part of this exercise was working with people from all levels of experience. I worked with a lawyer, a lab professional, and a student fresh out of undergrad not to mention our JHU instructor was an industry expert with FDA background.
What are some of your future aspirations professionally? Becoming a part of an executive leadership team who helps to drive products that help people in their everyday lives and to continue to grow and gain more experience as a regulatory affairs professional.
What advice would you give prospective students who are thinking about obtaining their Master’s degree from Johns Hopkins? The advice I would give is to get to know your classmates in the program and build a professional networking resources, work as a team, connect and learn as much as you can from one another, learn different perspectives from everyone because you never know what you will face in a real-world experience and it helps to be able to have a resource. Also, make sure to keep up with your JHU program tips, tricks, and tools from your instructors for reference. Keep up with the lot of Hopkins materials, (notes, books, etc) and apply them to your real work experience.
Teagan Walter, Class of 2014
What is your favorite part of the Regulatory Science program? The variety of coursework was extremely helpful for giving me a good, diverse overview of quality and regulatory matters. Through the required courses, I learned about several things that have been extremely relevant to different aspects of my work, but I also got to tailor my degree to include the topics I was especially interested in, such as biostatistics and legal/ethical aspects of regulatory affairs.
Why did you choose to get your Master’s degree from Johns Hopkins? I started the program while finishing up a PhD and continued through getting a full-time job, so the flexibility in the program was essential. The fact that the degree could be completed 100% online was very important for me, because I wanted to make sure I was getting a good education and experience, but wasn’t able to relocate permanently or even temporarily. I also credit the instructors for making an exceptional effort to accommodate different schedules while not compromising course content and experience. The fact that the instructors are people with relevant industry, academic, and FDA experience meant a lot to me, as I knew the courses would not just be consecutive lectures out of a book, but lessons that were deemed relevant and important to professionals in the field.
How has the program helped you? This program was absolutely essential for my transition from academic biomedical research into regulatory affairs. Through the program, I learned enough about the field of regulatory affairs to confirm that it was where I wanted to move my career. I was able to use the knowledge I gained to demonstrate and interest in and understanding of regulatory affairs to potential employers. Actually, I found out about my current job through the JHU AAP Career Services Newsletter. Now that I am working in regulatory affairs, I find that the knowledge I gained through the program not only has helped me to understand and perform my daily tasks, but I also have a wider appreciation for the whole quality/regulatory system. I can more easily understand quality engineering or clinical affairs, for example, when I work with those groups because of the broad curriculum of the JHU Regulatory Science program.
Susan Zecchini, Class of 2009
New to the pharmaceutical industry, I decided to apply to the Bioscience Regulatory Affairs program to gain a better understanding of the drug development process. Now in my last semester, I have a much greater understanding of the intricacies and nuances of drug development as well as the regulatory requirements that ensure the safe and efficacious development these products. The comprehensive studies offered through this program provide the opportunity to explore the substantive areas of biologics, pharmaceuticals, and medical devices while engaging students analytically.
At first, I was hesitant to pursue my Master’s degree online which is why I choose to go with a school with such a strong reputation. Although the studies are challenging, this program has been very manageable with my busy work schedule. The instructors are well versed in their areas of expertise and very supportive. I recently finished my term paper-Assessing FDA’s Categorization of In Vitro Diagnostic Multivariate Index Assays as Medical Devices via Guidance Documents Rather Than the Public Rule-making Process. My instructor, Dr. Thomas D. Colonna, commented that it was “an excellent paper”. Dr. Colonna’s recognition is a sample of the true dedication to encouraging students to their best and the commitment to excellence of this program. I plan to apply to the PhD program at Johns Hopkins after graduation.