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Karin Van Baelen, PharmD Head, Global Regulatory Affairs Janssen Research & Development, LLCJanssen Pharmaceutical Companies of Johnson & JohnsonAs the head of Global Regulatory Affairs (GRA) at Janssen, Karin Van Baelen leads an organization of approximately 900 highly-qualified colleagues who foster relationships with Health Authorities around the world and help Janssen deliver innovative healthcare solutions to patients. The GRA organization influences and interprets global regulatory requirements and enables Janssen to meet those guidelines. Karin oversees the development of regulatory strategy for products from all Janssen Therapeutic Areas, in addition to the delivery of high-quality, on-time regulatory submissions and approvals. Karin also engages in national and international policy development in the regulatory, biotechnology and clinical development arenas.
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.
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:
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