The following article was adapted from a translation of the original interview conducted in Chinese.
Annie Yin began her career in the pharmacy department of a hospital and rose to become the regulatory affairs director for Medtronic in China. She is also one of the faculty members for RAPS' Medical Device Regulatory Affairs Certificate Program in partnership with the National University of Singapore. During her career, she has witnessed the rapid development of China’s now flourishing regulatory profession. As a senior regulatory expert, she has a unique and deep understanding of the profession and its status in China. In the following interview, she shares her thoughts and analysis of the field in China today.
Regulatory Focus: When did you first become familiar with the regulatory profession? How did you enter this field?
Annie Yin: Two decades ago, I was the supervisor of drug storehouse management and drug purchasing in a hospital. I often needed to deal with sales personnel from pharmaceutical companies, but I had never heard of the regulatory profession. Frankly, I knew nothing about regulatory at that time. I asked some pharmaceutical sales people about it, but most of them had no idea.
I decided to leave the hospital when I began thinking about my future there decades later. By chance, I read in the Beijing Youth Daily that Eli Lilly and Company was recruiting regulatory personnel. I was very curious so I went in for an interview. To my surprise, I was selected from a pool of 99 applicants. I remember clearly that the interviewer asked why I applied for the position in the first round of interviews and I answered 'because I'm curious.' Although it may have sounded silly, it was the absolute truth.
RF: Why did you leave the pharmaceutical industry for the medical device industry?
AY: The regulatory field really fascinates me. I entered this field by chance, but I have become more and more interested in it as I have learned more. And, of course, the sense of accomplishment I get from the work I do is very exciting to me.
As the first stop of my regulatory career, Eli Lilly and Company is a diversified platform where I was involved in many different areas, including drugs, medical devices and veterinary drugs. I got a deep understanding of regulatory. After working in two other pharmaceutical companies—Roche and Sanofi-Aventis—I decided that I wanted to work in medical devices. Working as the greater China regulatory affairs director for Beckman Coulter gave me the opportunity to learn about an important branch of the medical device industry, in vitro diagnostics, which was a brand-new area for me. Beckman Coulter provided me with a broader platform to learn about global quality and regulatory development. I might be the first regulatory employee in China who became a regional director for a leading multinational medical device company in 2009.
RF: What have you found are the differences between regulatory departments of pharmaceutical and medical device companies?
AY: Regulations covering medical devices were promulgated in 2000 but regulatory requirements were very relaxed and implementation at the government level was not strict. But the drug field was totally different as it has a relatively long history. China promulgated the first pharmaceutical administration law in 1985. It is a relatively mature system with strict implementation. To be frank, the difference in implementation conditions at the government level causes the regulatory departments of pharmaceutical and medical device companies to operate differently.
In pharmaceutical companies, regulatory has been seen for a while as an important department, playing a critical strategic role. In medical device companies, regulatory hardly received attention. It was usually the executor at operation level, and seldom participated in strategy formulation. Moreover, it often received challenges and even blame from other departments during implementation. However, with the continued evolution of China’s device regulations, companies that have failed to adapt have faced regulatory setbacks and relatively long registration times.
In terms of the educational background of regulatory personnel, those in pharmaceutical companies tend to have majored in medicine or clinical medicine. Pharmaceutical companies have had an excellent, mature training system for regulatory personnel, as well as a clear division of labor, making the regulatory team very professional. On the other hand, the educational backgrounds of regulatory personnel in medical device companies were varied, as there were lots of product categories, and regulatory was viewed as administrative work in most device companies. All of this has been a result of companies’ ignorance of the important of regulatory expertise. It has been very hard to change such these entrenched perceptions in the medical device industry.
RF: In your opinion, what's the role and function of the regulatory department in an enterprise's strategy and business development?
AY: The regulatory department should be a company's strategic partner and a participant in strategy formulation, because a company's future development direction and product strategies must be consistent with a country's policies and orientation. The regulatory department should also be the company's pioneer that helps open new markets because there is no sale without registration. It should also be a company's guard because proper handling of adverse events and product recalls after launch can help a company protect both its revenue and reputation.
The regulatory department should be regarded as a front-line department that deserves the same respect as a company’s sales department. Moreover, it should be represented in management and participate directly in company decision making.
RF: What has been the greatest challenge you have encountered?
AY: A regulatory department faces pressure from both the regulator and the other departments within the company. For a multinational company, the regulatory department is caught in the middle because of China's regulatory system and requirements, which are different from those of other major economies in the world such as Europe and the US. With China's relatively long examination and approval timeframe, and challenging registration requirements, it is difficult to manage the expectations of the company's marketing department.
RF: In your opinion, what are the three most important qualities or capabilities that an outstanding regulatory professional should possess? Where should regulatory talent cultivation start? In which aspects can professional institutions like RAPS offer help?
I think EQ (emotional quotient), creative thinking ability and integrity are the three most important qualities that an outstanding regulatory professional should possess.
Regulatory is a science and a discipline. Regulatory talent cultivation is a very complex issue. Before connecting with RAPS, I was overwhelmed by the difficulty of providing professional resources and training tools for regulatory staff within the company. RAPS has a group of very experienced and outstanding regulatory professionals. Apart from providing written lessons or trial lessons for listening, RAPS can organize some workshops using tools like case studies and analysis where experienced professionals can help participants develop better understanding and improve skills like communication and logical thinking ability. RAPS’ competency model can also provide some specific direction.
In my opinion, it's not sustainable to enhance the capability of the regulatory department through continuous recruitment alone. From the perspective of the company's development or an employee's personal development, systematic training can promote capability enhancement and strengthen the staff's loyalty to the company. This can't be realized just through recruitment.
RF: Do you have any advice for those just entering the regulatory profession?
AY: Regulatory personnel must keep compliance and integrity in mind, and should avoid any type of deception or concealment. They should communicate internally and externally with integrity and help the regulatory department maintain consistency with stakeholders inside and outside the company.
Never give up easily. Treat problems and treat people with perseverance. Always be curious and ask yourself questions such as 'how can I do it better?', 'can this problem be solved in another way?', 'are there other better or more clever methods?', and 'how can I avoid repeating similar mistakes?'
Be willing to collaborate. Given current regulatory requirements, it's nearly impossible for you to finish a complex registration project alone, and you should learn to find appropriate internal and external resources. With the development of the medical device industry and the improvement of China's regulatory system, requirements are becoming increasingly complicated and cross-department cooperation is a necessity. New and experienced regulatory professionals should be honest about their own shortcomings and actively explore ways to fill gaps in knowledge or experience, and achieve work goals through effective cross-department communication.
To quote an experienced regulatory professional in the medical device industry who I respect very much, 'a humble family does not determine a humble future.'If you don't have an extensive regulatory background or knowledge, you can help make up for it with other skills, such as project management or communication skills. Registration of products requires a variety of knowledge and skills.