Successful Women in Chemistry - ACS Publications - American

Chapter 19

Susan Ε. James, Vice-President of Worldwide Regulatory Affairs and Regulatory Compliance: Chemistry around the World

Downloaded by CORNELL UNIV on May 30, 2017 | http://pubs.acs.org Publication Date: June 28, 2005 | doi: 10.1021/bk-2005-0907.ch019

Jacqueline Erickson GlaxoSmithKline, 1500 Littleton Road, Parsippany, NJ 07054

This profile highlights Sue James. In her career, Sue has taken on a variety of challenges, which have led her from being a development chemist in the United Kingdom to a successful position as the Worldwide Head of Regulatory Affairs and Regulatory Compliance, based in the United States.

Sue James is Vice President of Worldwide Regulatory Affairs and Regulatory Compliance at GlaxoSmithKline Consumer Healthcare. In this role, Sue is responsible for Regulatory Affairs, Regulatory Compliance, R & D Quality Assurance, and the Environmental Health and Safety Groups in both the United States and the United Kingdom. Sue started her career by earning a Joint Honors Degree in Chemistry and Biochemistry from a university in England. After earning her degree, Sue considered going on to earn a Ph.D. and entering academics, as she had several opportunities; including an offer of a research fellowship. However, she decided to gain some industrial experience instead. She applied for and obtained a job as a development chemist at Beecham Products (now GlaxoSmithKline Consumer Healthcare), in Surrey, England.

Early Career As a development chemist, Sue was responsible for formulation studies, analytical method development, setting up clinical studies, and transferring the

© 2005 American Chemical Society

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

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Susan Ε. James (Courtesy of Susan E. James.)

product to the manufacturing facilities. Her initial responsibility was in the analgesics group. However, the company had a rotation program, where Sue could move into different therapeutic areas such as cough/cold, vitamins, antacids, and topical products. The end goal of developing a product was to submit a registration that would allow a product to be sold over the counter (OTC). This was Sue's first exposure to Regulatory Affairs, and as the development chemist she was responsible for generating the data and formatting it into documents so that the Regulatory Affairs Group could then submit the registration. After a few years as a development chemist, Sue applied for a position in Regulatory Affairs but did not obtain that position. However, she continued to work with the group, especially in the area of European and international registration of products. A few years later, Sue applied for another position in


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Regulatory Affairs and obtained this position. In this role, Sue worked on a variety of regulatory submissions in England and Europe, including the prescription to O T C switch of Tagamet®. At this time, Sue's husband, also at GlaxoSmithKline, was given a transfer to the United States. Fortunately, Sue's manager, who had responsibility for worldwide regulatory affairs, also had an opening in the United States. Thus, Sue became U.S. Regulatory Affairs Manager, despite an initial lack of experience with U.S. regulations. Sue had moved up the ladder and taken on additional responsibilities over the years, due to her success in each position as well as through various reorganizations within the company. When asked what took her to the level she is at, Sue replied "being in the right place at the right time, as well as taking risks and opportunities when offered."

Work Climate Changes One of the questions posed to Sue was a question about how the work climate has changed since she first started in the industry. Sue described work as oscillating with peaks and troughs and that the oscillations occur at a much higher frequency now. The expectations are much higher, and doing things right the first time is now essential. However, much more flexibility around work hours, more accommodation of work-life balance, and more women in senior positions are available, according to Sue.

Success Sue believes that "success is achieving what I set out to achieve, as well as doing the right thing in the right way." Success is a balance between achieving the corporate goal and the manner in which it is achieved. Sue does not really believe that success requires compromise, but it does require teamwork at the corporate level and clear prioritization at a personal level. Sue also indicated that to maximize opportunities, you might have to sacrifice something. In her case, she relocated from England to the United States. She noted it can be tough, especially when you are so far from family and friends but that "to make it workable, you have to deal with sacrifices." Sue also noted that less than 50% of the people offered international opportunities take the assignment but that these opportunities can be especially valuable in a career. Sue believes that a key trait for success is integrity, no matter what the position. Sue also indicated that a successful scientist should have resilience or determination and be detail-oriented in order to work efficiently. A successful manager should have the ability to see the big picture and have a strong focus on



120 goals, mixed with degrees of empathy, understanding and flexibility. Sue also commented that a successful leader should have good communication and motivational skills, as well as demonstrating believability and technical competence. For career success, Sue believes that delivering results in a culturally appropriate manner and choosing the right team members are two of the most important skills. For her own professional development, Sue reads the Harvard Business Review and books on leadership, as well as books and magazines relating to regulatory affairs. In fact, Sue recommended the Harvard Business Review, and a book by Larry Senn, titled Secret of a Winning Culture: Building Hizh Performance Teams as excellent publications for those interested in leadership. She also networks, primarily through trade associations, but thinks that meeting business objectives and leading her team are more important uses of her time.

Balance On the subject of work-life balance, Sue indicates that she sets clear priorities, and on a case-by-case basis she determines what takes precedence. Sue and her husband schedule vacations twice a year, during which she won't check her voicemail or e-mail. She also schedules time to attend school activities for her two children so that she works around those activities. Sue has also found a way to schedule time for herself. Because she is very results-oriented, she enrolled in a martial arts school. This activity requires class attendance to progress to the next level, and the exercise of punching, kicking, and yelling is good for relieving stress. Finally, as a manager, Sue also encourages others to set priorities and balance their work-life activities, as she believes it is important to lead by example.

Mentors For the most part, Sue's mentors have been her direct managers. They have helped by providing clear direction and constructive criticism. " Y o u should never underestimate the value of constructive criticism," said Sue. Her family members have also been key mentors. Her husband is very supportive. He has always helped her to keep a clear perspective and a balance at work and home. According to Sue, some of the key traits in a good mentor are that they should be approachable and a good listener. They should also have good insights derived from life experiences and a high emotional intelligence. A t the same time, a mentee should be committed, goal-oriented, flexible, and self-motivated.


121 They should have potential in their field and understand their responsibility for their own development, says Sue. In order to find mentors, Sue advised students to do research and be inventive in reaching out and contacting people. She also suggested summer internships as a way to gain hands-on experience and find people interested in mentoring. Often the human resources department of a local company can find someone within the company to mentor a student, and some companies have high school outreach programs.


Final Thoughts Sue believes in order to have a satisfying career, you should choose something you enjoy, for "nothing is more miserable than spending eight hours a day, five days a week on something you hate." In addition, a person should be open to trying new things. As your experience widens, you may find something that you enjoy more and are better at than what you initially started out doing. Finally, Sue advises that when starting a career, you should have "positivity, persistence, and patience." B y that, she means that you should have a positive attitude and approach, and deliver your best all the time. She also said " Y o u need to be resilient and cautiously ambitious—and don't expect too much too soon and don't bite off more than you can chew."


Successful Women in Chemistry - ACS Publications - American

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