John Hoare discusses the skills most useful to his regulatory role at Viatris.
John Hoare, the device technical regulatory manager for global device development at Viatris, has been with the company for more than two years. In his time there, his role has demanded a range of skills in areas such as the technical aspects of medical devices, combination products, regulatory compliance and ensuring that products meet safety, efficacy and quality standards throughout their lifecycle.
“Key responsibilities include staying current with and interpreting relevant regulations set by various health authorities,” said Hoare.
What first stirred your interest in a career in this area?
My degree was in chemistry. At that time, the university academics were less aware of what other opportunities lie beyond research and lab work. My placement year was with a central quality group that included the life cycle management of medical devices in the EU post-launch. While the group was small and office-based, we interacted with the global supply network. I got to work on change controls, batch record reviews, managing customer feedback and investigations, safety reporting to agencies, supplier agreements and regulatory dossier reviews.
At that point, it all just clicked as the team was welcoming and supportive, like a family. The work was something I enjoyed, being able to apply my degree in another way and seeing these global medicines impacting and changing the lives of millions of people. I particularly liked working with the regulatory affairs group and after my degree finished, I got a job within that team.
What brought you to your current job?
Straight out of school, I worked for pharma and medtech companies and then transitioned into the world of start-ups for four years, before consulting for one year. While I had worked with medicines and cosmetics, my primary focus had been medical devices. At Viatris, I could leverage my medical device knowledge and deepen my drug product experience while learning how to navigate the regulatory landscape at the interface of these two very different regulatory frameworks.
Today, I am responsible for authoring and reviewing the device content of regulatory applications and agency communications. This includes liaising with notified bodies to obtain notified body opinions for EU submissions. I conduct classification assessments and in partnership with Global Regulatory Affairs, define technical regulatory requirements and strategy in compliance with the relevant legislative frameworks.
My role at Viatris has enabled me to grow professionally and contribute at a broader industry level. This year, I was given the opportunity to join the Medical Device Task Force of Medicines for Europe, where I collaborate with peers across the sector to help shape regulatory policy and share best practices.
What were the biggest surprises or challenges you encountered on your career path and how did you deal with them?
The first start-up company I joined failed and liquidated. The start-up had great technology with solid data and strong development and manufacturing teams behind it. While it was a shock and you can get absorbed with your own situation, there were other, bigger things I needed to focus on outside of myself. I had a team and a clinical site with subjects in the middle of an implantation study to consider. I also looked at this as a learning opportunity, to understand what happens when a company liquidates, from a regulatory compliance perspective.
I stayed on as a contractor for the liquidator and worked with regulators to develop a strategy to help bring the operations to an end. Importantly, it taught me how to remain agile and solution-focused in the face of uncertainty. These skills have been instrumental in my current role, where I regularly navigate shifting business priorities and adapt to evolving requirements. The ability to stay composed, learn quickly and pivot when needed has helped me contribute meaningfully to innovation and operational resilience in a dynamic business environment.
Was there any one person who was particularly influential as your career developed?
It is difficult just to pick one person. Fortunately, early in my career my first three managers were great examples of leadership. All had very different personalities and styles of management, but each were technical experts in their fields and took time to share that wealth of experience and knowledge with me. They put a lot of trust in me, a student or fresh graduate, allowing me to gain broad experience in quality, regulatory and medical relatively fast for someone in this space. That is something that stuck with me and I have tried to emulate as a team leader for junior colleagues looking for opportunities to grow.
What do you enjoy most about your job?
I enjoy the variety, as no day is the same and you are always learning, having to adapt. It is the challenge of needing to understand various products, technologies, therapeutic areas, patient needs and navigating an ever-evolving global regulatory landscape, through all stages of the product lifecycle.
As part of a global healthcare company, I get to collaborate with people from around the world, who have been brought together in this fantastic way to develop, manufacture and supply life-changing and life-saving products.
What aspects of your personality do you feel make you suited to this job?
Viatris’ device development team plays a leading role in connecting scientific innovation and public health, ensuring that device and combination products are developed and marketed safely and effectively. Regulatory brings everyone and everything together. I appreciate the ability to connect and collaborate which is key to understanding the needs and perspectives of diverse groups within the company and by regulators, to bring a product through development, regulatory approval and to the patient. I place value in doing the right thing, because at the end of the day, I know patients are counting on us.
What advice would you give to those considering a career in this area, or just starting out in one?
We often work with a variety of team members who are passionate about their work. Where necessary, have the courage to take difficult and sometimes unpopular decisions to show how you are enabling success, bringing necessary guidance, direction and clarity for a successful product. Your contributions protect patients and the integrity of the company.
What skills do you think are most in-demand in this industry right now? What advice would you give for upskilling?
The regulatory environment is always evolving, requiring constant education and development. You need to be up to date with the latest industry technologies and their respective legislative frameworks. By way of example, the use of software and digital healthcare is taking off. Anything you can do to develop in that area will aid your career prospects, within the industry or as a regulator.
That applies for products with clinical applications or the use of digital in daily tasks, regulatory databases, data analysis or submission generation. There is a huge need for regulatory professionals who can understand these innovative technologies, determine the relevant applications, appreciate the ethical implications and help develop appropriate legislation.
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