Regulatory affairs professionals must be excellent project managers. It’s not enough to simply copy/paste regulatory timelines or wording from legislation, check the available documentation from your previous projects and slightly adapt. There are many potential pitfalls that make regulatory job unpredictable and you should be able to use your project management skills to competently navigate through unknown territories.
So, what are some of the crucial project management skills that you need to develop and become a better professional?
How risk averse is your company or a client? Sometimes they want you to be creative, think outside the box and propose new and riskier approaches, other times they just want you to follow common and proven strategies.
Have you identified all potential risks, including all delays, overlapping regulatory activities that might block team capacities or tricky questions agencies may ask and potential answers you and your colleagues are going to provide? How regulatory tasks align with the proposed start of crucial clinical trials, e.g. agency meeting feedbacks that impact study design, Paediatric Investigation Plan submissions, etc.?
As a minimum, you should get used to proactively identify all potential regulatory risks, clearly document them, analyse and define impact and likelihood of happening. Many professionals are already doing this, either intuitively or as part of the higher “Core” team efforts to identify and categorize all project risks, however you need to assure that both your Regulatory group and the whole development team are on the same page.
Now when you identified and classified all those risks, you need to assess how likely is that a certain situation occurs and what would be the impact to the project. The whole development team needs to understand what situation might likely occur and what are the ones having the highest impact, if occurred. Develop a clear mitigation strategy and contingency plan if those situations materialize, share them with your team and keep revisiting the existing risks throughout the project lifecycle.
There is a famous saying that 90% of the project management is communication and that’s why you should master the art of clear and precise communication. Be assertive and firm but also emphatic and proactive. Don’t underestimate the power of words and risks of sub-optimal communication. If you were so unlucky to have your meetings cancelled or scheduled without your knowledge and if you already experienced the pain of misaligned goals, shifted priorities, double work, absent key team members during the high-pressure times, missed deadlines, wrong regulatory commitments and wrong versions of the documents then you already know the consequences of bad communication.
Your management should be proactively informed about upcoming regulatory interactions. Never assume that everyone knows where to find information, even if you are using fancy data management systems and other knowledge depositories. It is your task to manage the regulatory communication within the development team as well as communication with your senior management. Senior management is often traveling or attending high-impact business meetings and do not have time to search for information. They require clear, concise and timely information, especially for complex situations.
Nothing worse than realizing that your senior management had a different understanding of your regulatory strategy.
Communication becomes even more important when working with multi-cultural team that works remotely and use different tools and systems for information sharing.
Is there anyone who likes writing dry regulatory plans that are completely detached from reality? The sad reality of regulatory planning is that it sometimes looks like wishful thinking, instead of a realistic step-by-step approach to problem solving. Who hasn’t heard from management that timelines must be shorter, approvals should come earlier and came across a bad regulatory advice coming from non-experts? The best way to assure clarity and realistic planning is to involve your development team in defining the activities that should be done, including the deadlines and milestones. Brainstorm with your team, review the lessons learned, timelines and regulatory communication from your previous projects, talk to subject matter experts and don’t forget to document your assumptions and estimates. As you plan, your confidence in project’s success should gradually increase.
Don’t forget to develop a clear regulatory schedule (timelines) only after you did your risk identification exercise. And develop a realistic plan, not wishful thinking. This plan should not change daily, since you put a lot of thought in it together with a larger team and have considered all constrains and non-regulatory tasks that need to be done (e.g. initiation of clinical studies, production of clinical or commercial batches of drug, stability data obtained, etc.).
This is just an excerpt of some crucial project management skills that have been proven to have a significant impact on any project in drug development. There are certainly some others that are important and contribute to the project success. Share with us your thoughts on any other project management skills of importance in regulatory affairs.