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RAPS' Latest | 09 June 2016 | By Zachary Brousseau
The sheer volume of laws, regulations and guidance documents covering medicines and medical technology means new regulatory professionals have a lot to learn. Even those who have regulatory experience may find themselves behind a steep learning curve when taking on new responsibilities or switching jobs. What should new regulatory professionals or those changing product lines or industries do to position themselves for success?
David Chadwick, PhD, RAC, FRAPS, who is director of regulatory affairs and regulatory science with Cook Inc., will be among the faculty of the US Regulatory Essentials, Medical Devices and IVDs workshop, 17 September at RAPS’ 2016 Regulatory Convergence in San Jose, CA, and he has a few pieces of advice to offer.
Chadwick advises regulatory pros to first master the basics—the law and regulations pertaining to their areas. “These represent the world we work in each and every day,” says Chadwick. “These form the bedrock. From here all discussions and growth and arguments are based. It is necessary that you learn well and be able to speak from a position of authority.”
Some who are new in their roles may be hesitant because they know they still have a lot to learn, but Chadwick tells his newer colleagues to be proactive from the start. “Jump in. Learn the regulations. Be an asset to your teams,” he says.
Inexperienced regulatory professionals certainly do have much to learn, but they can learn faster by being inquisitive. “Ask questions,” Chadwick advises. “Ask enough questions in order that you can tell a complete and thorough story.”
He also reminds colleagues to be mindful of the bigger picture, and remember why your work as a regulatory professional is so important. “Take pride in your role in advancing medicine, in your role in helping patients to live longer or better or more enriching or more rewarding lives,” he says.
No matter your experience level, colleagues and fellow team members can be great assets, not just on the regulations and procedures, but on myriad dimensions of your job and the related areas you will need to understand. “Seek out experienced mentors who can teach you about strategy development, predicates, clinical studies, quality systems, design control, postmarket and total product lifecycle,” says Chadwick.
Once you start to feel comfortable with your knowledge of the product line you work with, branch out to learn the regulations covering other products. If you are working on devices, begin learning drug regulations or vice versa. “One never knows when questions on a possible combination product will come your way,” says Chadwick. “Better to know these extended regulations; at the very least to know where to research to bring the needed answers.”
When it comes to interactions with officials at the US Food and Drug Administration (FDA) or other agencies, Chadwick believes it is important to keep in mind that regulators are human beings too. “They are people just like the rest of us. They have families and lives and ambitions and problems,” he notes.
“What I teach and strive to exemplify to those that work with or learn from me is to be respectful, to speak from the law and the regulation and the specific guidances related to your products,” he says. “Regulatory affairs is relationship based.”
Finally, and perhaps most essentially, Chadwick emphasizes the importance of ethics. “All we do and all we say in regulatory affairs and in life is based upon a few guiding principles,” he contends. “These are that honesty and integrity are the hallmarks of who we are and what we do. Your reputation is the most valuable thing you have and needs to be protected at all costs. That is all we really have.”
RAPS’ US Regulatory Essentials, Medical Devices and IVDs workshop takes place 17 September as part of RAPS’ 2016 Regulatory Convergence, which runs 17–20 September in San Jose, CA.
Tags: advice, new regulatory professionals, new professional, entry-level