The Regulatory Affairs function of one of the world’s largest pharmaceutical companies was struggling to keep pace with increasing volumes of regulatory submissions and increasing burden associated with changes in regulatory requirements. The “shifting sands” of the environment had led to an over-reliance on it’s people to “keep going to the well” to get through critical situations.

How regulatory submissions were managed throughout the product lifecycle had grown organically to meet the needs of an evolving and growing business and was inconsistent across different product families, regions and internal companies. The ownership of key parts of the submission management process was loosely definedand variable, and teams were often unclear on priorities and how they could help each other.

The project team was tasked with optimising, harmonising and standardising the submission building processes with a view to gaining efficiencies and improving quality of service.



For us, the starting point of any initiative is understanding why you should make a change. Be this an organisational transformation or solving a minor headache, spending some time reflecting on the reasons why you want to do this is very valuable. This is not always the easiest thing to do, and declaring personal motivations in front of your peers requires confidence and trust. The project team embraced the opportunity and reflected deeply on their motives. The result was a moving articulation of the imperative to change based on personal reasons, business reasons and most importantly for this group, wanting to improve the quality of their patient’s lives. And it created a bond and a resolve that could not be broken.

Once the team had settled on their “Why”, the next logical step is to understand what needs to change, be standardised and be optimised. Knowing the most important things to target requires a deep understanding of how things currently are and is crucial to avoiding building in, or acting upon, assumptions. The team resolved that in order to decide how things might work, they first needed to know how things currently work. Given that the company evolved through an organic process of growth and assimilation, understanding the variation in detail is a critical step. In the spirit of rapid learning, they committed to learning as much as possible in a 10 week period, and the outputs of this learning would facilitate better decision making and a better vision of the future. The rapid learning cycle involved information gathering through various sources such as process mapping, subject matter expert interviews and data analysis, as well as pulling together as much information as possible from previous initiatives.



During the course of the first learning cycle, the team kept a log of pain points that their colleagues encountered on a day to day basis, no matter how big or small. They also solicited information about pain points for their customers and added these to the log. In a workshop setting, the team waded through a long list, and reflected on each, without attempting to solve the problems individually. They used affinitisation methods to group the pains based on their severity and “bucketed” them into categories. As you can imagine this is a difficult session and the team relied heavily on their “Why” and a “no blame” culture to get them through. Buy the end of the day, what seemed like an imposing and never-ending list of problems and inadequacies had been converted into a small and distinct set of challenges that the team must overcome, setting them up nicely for Day 2, where they could start to ideate on possible resolutions.

Having acknowledged and reflected on all of the pain and missed opportunities, the team turned it’s attention to looking forward and resolving their problems, and their customers’ problems. Attention turned immediately to resolving the problems faced by their customers (in this case the customers included the health authorities as the primary customer and various  business units and affiliates as secondaries). The team decided to focus on the capabilities that they would need in order to deliver the required value and meet their customers’ needs. This included identifying new capabilities to address unmet needs, or revision of existing capabilities to resolve issues around the customers’ quality of service needs. Once a complete set of capabilities were identified, the team reassessed their OWN problems and asked themselves how many of their problems would also be addressed by focusing on the needs of the customer and to their amazement, all were satisfactorily resolved by the new capability set.  The team now had a Vision of where they needed to go, for the benefit of themselves and their customers.



At the end of a 12 week period, the project team had certainly travelled on a journey. What could have been a “run of the mill” process improvement project had transformed into a coherent and informed articulation of what the Regulatory Affairs function SHOULD be in order to meet the needs and expectations of the customers, and to keep pace with the “shifting sands” of the regulatory environment.

The people at the heart of the processes had proposed radical changes to the services they offer to their customers, the quality of services, and the productivity of the processes required to deliver these services in a cost effective way. Most importantly, they owned these proposed solutions, and were very clear that by implementing them over time they would be making a difference and connecting to the “Why they articulated at the outset.

Avellana are very thankful for being allowed to accompany them on their journey.