Elizabeth Yamashita, Group Director of Global Regulatory Sciences

Chapter 11

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Elizabeth Yamashita, Group Director of Global Regulatory Sciences: The Challenge of Evolving Regulations Jacqueline Erickson GlaxoSmithKline, 1500 Littleton Road, Parsippany, NJ 07054

Regulatory Affairs in the pharmaceutical industry is a growing field with many opportunities for scientists who wish to use their knowledge and skills in this area. This profile highlights Liz Yamashita, a Regulatory Professional in the pharmaceutical industry.

The pharmaceutical industry is filled with exciting careers within the chemical sciences. Some are more traditional laboratory careers, while others are outside of the laboratory. Elizabeth Yamashita started her career in the laboratory but has become successful in a regulatory affairs position. She is currently a Group Director, Global Regulatory Sciences-CMC (Chemistry Manufacturing & Controls), at Bristol-Myers Squibb Company, one of the world's largest pharmaceutical companies. Wishing to follow in her father's footsteps, L i z became a chemist. She earned her B.S. degree in Chemistry at the University of Rochester and joined Bristol-Myers Squibb after college as a process chemist. Her primary reasons for choosing the company included its location and proximity to the University of Rochester, as well as the friendly people working there. While working process chemistry, L i z was fortunate enough to have a manager recognize her additional talents. Together they worked to find other opportunities within the company where those talents could be better utilized. After nine years in Process Chemistry, L i z switched careers and moved into the C M C Worldwide

© 2005 American Chemical Society

Hinkle and Kocsis; Successful Women in Chemistry ACS Symposium Series; American Chemical Society: Washington, DC, 2005.

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Elizabeth Yamashita (Courtesy ofElizabeth Yamashita.)


71 Regulatory Affairs Department. A few years later, she was offered an opportunity in the Global Marketing Department, where she performed regulatory-related work. She found this position to be very rewarding, and the experience in this department gave her a perspective on the pharmaceutical industry that not many chemists have the opportunity to obtain.


Balance After a few years in Global Marketing, L i z transferred back to the C M C Regulatory group, looking for more balance in her life and time to spend with her husband, four children, and pets. In her spare time, she also enjoys cooking and gardening. L i z indicated that she tries to allocate her time in order to separate her work and home life. A t home she concentrates on her family, while at work she prioritizes so that she can stay focused and efficient for the tasks at hand.

The Regulatory Field Regulatory affairs involves the interface between a pharmaceutical company and a health agency, such as the Food and Drug Administration (FDA). Prior to registration or approval of a new pharmaceutical compound, data are reviewed to ensure the quality, safety, and efficacy of that compound. The Bristol-Myers Squibb C M C area focuses on the quality of the active ingredient and drug product. L i z has responsibility for global C M C regulatory strategy, supporting three different therapeutic areas, and has gained experience in every stage of development, from early development to maintenance of marketed products. Currently, she leads a team of approximately 12 people who are responsible for all aspects of C M C regulatory documentation. When asked what she loves most about her job, L i z said that she enjoys the challenges and constant learning that go hand in hand with changing and evolving regulations. She also said that she works with wonderful people who really care about quality work and ensuring that the job is well done. When asked about professional development, L i z replied that working in Regulatory itself is a form of professional development, as the regulatory environment is constantly changing. In order to work in this field, a person must keep up with new and changing regulations and guidances. Additionally, L i z attends seminars to learn about the latest regulatory approaches or advances in a particular therapeutic area. She networks and stays on top of the job market, both to potentially aid her career and to look for new talent. L i z maintains her Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) and is an active member of that organization.


72 She believes that women who are open and creative in their approach to work would find regulatory affairs rewarding. Regardless of what one chooses, L i z said that work should be fun and personally rewarding.


Success L i z believes that she has been exceptionally lucky, as she has had managers and mentors who recognized her talents and pushed her to accept challenging projects and assignments. She continues to have excellent managers who push her to try new things as well as provide her with support. L i z noted that two of her three managers in the C M C group were women who understood the need for work-life balance and that these women have provided exceptional guidance and support. In addition to the mentors that she has at work, a great deal of credit goes to her parents who she still relies on for advice. She also believes that success is internally motivated and that "it's about setting your own goals and working to achieve those goals. Success is about making positive choices, and you should never compromise yourself to achieve those goals." She stated that she never had to sacrifice in order to become successful. L i z also noted that she has had three different careers within the one company, which has helped her reach her current level of success. Although the careers seem very different, L i z indicates that similar skills are used in every position and that all of the positions have had a strong basis in science. The positions all required good communication skills, as do most scientific jobs. Additionally, both Regulatory and Marketing value the ability to anticipate changes, negotiate, and interpret requirements.

Climate Changes When asked how the work climate has changed over the years, L i z replied that in the past, companies, even large ones, had more of a family feel. In contrast, today's environment expects employees to actively manage their own careers. In many respects this attitude gives the employee more autonomy to go after what they want rather than waiting for advancement to be handed to them. However, movement across companies is often the result.

Final Advice As advice to others, L i z thinks that you should constantly look for opportunities and "never sell yourself short." Networking is the key to finding


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those opportunities, and professionals should maintain contacts both within and outside their discipline. She also noted that women tend to take personal responsibility for everything and then become too busy to network, which is a shame. In order to advance in a career, communication and problem-solving skills are as essential as execution or doing a job well. She strongly believes in teamwork.


Elizabeth Yamashita, Group Director of Global Regulatory Sciences

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