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5 Ways to Shape a Regulatory Affairs Workforce for the Future


Pharmaceutical regulatory divisions should use the same discipline, rigor and focus on the talent pipeline as they do the product pipeline, writes Karin Van Baelen.

Karin Van Baelen

With the ever-changing healthcare landscape, I encourage my Global Regulatory Affairs (GRA) team at Janssen R&D to be nimble, curious and forward-thinking in everything they do. Why? Because with more than 30 years spent in pharmaceutical R&D and regulatory, I am witnessing firsthand major transformations at an unprecedented pace and magnitude in the area of science, novel technologies and digitalization. New stakeholders in healthcare delivery and regulation, non-traditional competitors, and empowered, engaged patients are changing the dynamics substantially. Within Janssen R&D, we are at our best driving regulatory strategy and executing flawlessly, establishing reliable relationships with regulatory authorities around the world, understanding the needs of patients, doctors, nurses and caregivers. We need to adapt our approaches with short- and long-term goals to evolve to and meet the demands of patients, consumers, industry stakeholders and internal and external collaborators.

I’d like to think that what truly sets us apart as a regulatory affairs group is our ability to balance agility and consistency; we are enthusiastically learning, experimenting and shaping the future, while remaining excellent, accountable and resourceful in execution. It starts with recruiting, developing and retaining the best talent. With that in mind, here are five must-have qualities we value most in establishing our future-forward workforce.  I consider these universal for any aspect of the regulatory industry, to be as effective as possible in a complex, rapidly-changing and connected world:

  • Building Effective Teams: As with many organizations, the Janssen R&D GRA group recognizes the importance of investing in developing the most effective teams – especially in a fast-paced industry where productivity is key. We invest in achieving a common understanding and alignment on our mission and purpose, and on how we need to work. We work through what will hamper success and embrace psychological safety so that difficult and honest conversations are possible. It’s important to remember that building an effective team begins by bringing together a diverse and talented group of individuals with various skill sets, making it a priority to build relationships individually, and then to present opportunities for the team members to connect with each other. It’s rewarding when the process unveils itself and you begin to see your team come together, trusting and supporting one another.

  • Managing Ambiguity & Instilling Trust: We work collaboratively with our partners to provide strategic insight and offer different perspectives. As you begin to build relationships, trust is a factor that can be, at times, tough to build. Trust is gained through offering deep expertise, delivering results and being accountable. Having an open mind and willingness to learn helps to manage ambiguity. However, with the ever-evolving adventure that is healthcare, our one constant remains the same: to abide by our J&J Credo, established 75 years ago, which puts the needs and well-being of the people we serve first – doctors, nurses and patients. Simply put, we care. This is our DNA and as we grow as a team, we look for others built with the same DNA. That said, should there be a question of trust or general uncertainty, we refer to our mission and reason for everything we do – “the patients are waiting”.

  • Being Resilient & Courageous: Problems are solvable. Keeping in mind our mission, our work is backed by our mantra: “Here’s how we can, not why we can’t.” A successful regulatory affairs team must navigate towards being a curious explorer, be externally focused and take on new opportunities to learn and adapt. Remaining resilient and working diligently toward resolutions is what will set your organization apart. Do what is possible so your team never looks back and wonders “what if?”; never settle for no, and don’t be afraid to blaze the trail.

  • Valuing Differences: With a vision of being a premier regulatory organization, we are very intentional in our approach to talent. In recent years, especially, we brought on people with very different experiences and perspectives that span beyond regulatory expertise and this has enriched our effectiveness. As a global team, we employ people from around the world, and we also have a high representation of women throughout the GRA organizations at all levels. Identifying individuals early in their career is also important, particularly attracting enthusiastic Gen Zers and Millennials who are eager to shape the future. Programs such as intern and fellowship programs help us to stay connected to new generations entering the workforce. Bringing in different experiences and perspectives can give rise to new opportunities or solutions that were otherwise unknown, spurring innovation, and in turn, helping to lead to success.

  • Being Resourceful & Responsible: An organization that is built on strong, foundational resources is key, but what’s more important is being resourceful. Resourceful employees attain their goals, are responsible and accountable and challenge the status quo to always improve. Taking ownership for actions as it relates to individual task flow allows for a productive and efficient workplace and overall team success.

Finally, it’s important to remember that a high performing team is a reflection of its leadership. For example, I often remind myself of the “multiplication factor” – in other words, the behavior of a leader is disproportionally important, so leaders should be role models –  which is why I may refrain from sending an email on a Saturday or Sunday because I do not expect that of my team or want to set the precedent. It’s important to remember to take care of yourself, balancing your professional and personal life. It helps to always ask yourself the question of where you bring value and don’t spend much time in areas that you may not.

Molding the future of your workforce is all about unleashing the full potential of others and focusing on employee wellbeing so that they feel empowered, inspired and motivated to be their best as individuals – and put 100% into the success of your organization. In doing so, we honor our patients and their families – and do our part in shaping the healthcare industry today and for the future.

Karin Van Baelen, PharmD, Head, Global Regulatory Affairs Janssen Research & Development, LLCJanssen Pharmaceutical Companies of Johnson & Johnson

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