The following article was adapted from a translation of the original interview conducted in Chinese.
Two decades ago, unlike many of her contemporaries, Linda Lin decided not to pursue a job that would have been a more traditional choice for a woman in China, a job like teacher for example, to work in a joint-venture pharmaceutical factory in Guangzhou. Today, she is vice president of international business for Shanghai MicroPort Medical (Group) Co. Ltd. She also serves as a member of RAPS’ China Advisory Council. In the following interview, she offers her opinions on the regulatory profession and shares lessons from her experience for young Chinese men and women who may wish to pursue a regulatory career.
Regulatory Focus: Can you briefly describe your career and talk about what motivated you to enter the regulatory field?
Linda Lin: I knew nothing about regulatory before I was, by chance, transferred from Guangzhou to Beijing, to take charge of registration of imported drugs according to regulations. Then I began to learn more about it and began focus on regulatory.
In that era, there were very few specialists with backgrounds in devices or registration among those entering the regulatory profession. In my case, I majored in English during college, so I was very confused and uncertain when I stepped into this field, not to mention I didn’t have a clear career plan. I think it is not that I chose this industry, but that this industry chose me.
There were plenty of difficulties, but I persevered. After working in registration for a pharmaceutical factory for more than five years, I accumulated some experience and achievements, and gained a reputation in this field. Then, I faced the first turning point in my career—making the transition to the medical device industry. Medical device companies in China at that time were much smaller than they are now, and quite a bit smaller than pharmaceutical companies. In 2000, China promulgated the first regulation on medical devices which stipulates the requirements for device registration. From then on, the medical device industry grew and gained awareness, and the prospects greatly improved for medical device regulatory professionals as the system become more established.
RF: What is the biggest challenge you faced?
LL: Everyone has to face numerous challenges in life, but what might be different is that I like challenges a lot!
In terms of the international environment, the regulations of various countries pertaining to multinational enterprises have been becoming stricter, but coordination between countries has progressed extremely slowly. This is the greatest challenge for multinational enterprises, and it is absolutely an unavoidable. Regulatory personnel must keep up with this complex and ever-changing environment where technology develops rapidly.
We often say that ‘regulatory is the strategic partner of business,’ but it is different from business departments. It’s still a challenge to make the company recognize the strategic position of the regulatory department and empower it with as much say in decision making as the marketing and sales departments. It is a challenge to earn respect and recognition from other departments. This challenge may be more arduous for some domestic small and medium-sized enterprises.
RF: How can the regulatory department strengthen its power within the company and earn respect and recognition from other departments?
LL: The regulatory department needs to improve its presence on its own. Both multinational enterprises and domestic enterprises know the importance of regulations and regulatory expertise now. A product can’t be launched without a registration certificate. But most importantly, the regulatory department should own strong core capabilities in order to strengthen its position.
While communicating with other departments, regulatory should offer some strategic and valuable suggestions based on the company’s strategic goals rather than focusing narrowly on its own issues. The leader of the regulatory department should maintain this strategic mindset and take a high-level view of situations so that other departments can truly respect and recognize us.
Fulfilling commitments is also very important. Each department encounters problems. But if the regulatory team passes on responsibility for problems, it cannot prove its value. We should have initiative and foresight, and discuss the causes of problems again and again to find feasible solutions. This is the basic capability that a mature regulatory department should own.
RF: In your opinion, what kind of qualities should an outstanding regulatory specialist possess? In which aspects can RAPS help regulatory personnel enhance their capabilities?
LL: A competitive regulatory professional not only needs to possess solid knowledge on regulations, but also needs to understand the responsibilities of, and connection and collaboration between, different departments.
There are two types of career development paths we usually talk about. One is the specialty development path, namely a vertical development path in specialty field. For example, let’s say someone has been focusing on registrations and dealing with FDA, so to grow he just needs to grasp the regulations of other countries within the same scope of responsibilities. Another is the management development path. Especially in China, people who engage in the regulatory field, or other fields like marketing and finance, tend to take comprehensive management positions within planning and leadership teams. This requires professional knowledge and very strong comprehensive capabilities such as communication skills, leadership and strategic thinking so that someone can lead his team to get the most out of it.
RAPS provides many training courses about topics such as global strategies for medical device regulations and communicating with internal and external stakeholders, so learners can improve their skills and convert knowledge into actual capability in practice. RAPS also provides the latest news and information about the regulations of many different countries, which has helped us closely follow important trends.
RF: Do you have any suggestions about career development for Chinese professionals just entering the regulatory field?
LL: First of all, I feel so happy for them because they’ve chosen a promising industry and the value of regulatory is very high. It is a good time to be in this field; there is great opportunity. However, as an old saying goes, ‘the one who comes to the foot of a mountain earliest does not necessarily climb to the top earliest’. To keep up with the fast-changing times, they should keep learning and making progress no matter which position they’re in. Their basic skills, professional ability and learning ability determine how far they can go. A good start does not mean continued success. They should work hard and not waste any opportunities.
There is something I value and often share with new professionals: the ‘three eyes’: a bird’s eye, an insect’s eye and a fish’s eye. View the overall situation and think about strategies with a bird’s eye; pay attention to details and realize effective implementation with an insect’s eye; and feel the changes and grasp the trends with a fish’s eye. If someone often uses the three eyes, he or she can challenge himself or herself continuously and innovate bravely in a complex and fast-changing environment and thereby becoming a highly competent regulatory specialist.
Max Chen is manager of marketing and communications, RAPS China.