Articles

Keys to Regulatory Operations Success

As a former head of Regulatory Operations for a global pharmaceutical company, I have learned some keys to success that I would like to share.   While these keys may seem like common sense, it is easy to lose focus in a fast moving organization.  Operational success is based on a clearly defined strategy, great planning and open communication to customers and project staff at all levels.  

Strategy should guide you in concentrating on the end goal and the steps along the way.  Sometimes the grand design could change during a project, but this should be avoided as it can result in delays.  For example, if the short-term plan to start a clinical study in the US in indication A is changed to move the study to Japan in indication B, there will certainly be delays from the original schedule.

Planning is the roadmap to the end goal.  A good outline uses the critical path to lead to the end product.   In a complex project, there are always surprises---the stability data will be delayed, the bioequivalence study must be repeated, and on and on.  Planners need to be closely linked to the working team in order to detect these changes and adjust the plan.  The working team is usually so targeted on individual tasks that they do not recognize the significance of a delay.

Communication is what glues a project, project team and their management together.  This conversation needs to be crafted to address the needs of individual groups thus not consuming too much of their time.  For example, a medical writer needs to understand how documents fit into the plan and the critical path.  The writer does not want a half day meeting laying out the great details of the idea, while senior management wants the succinct high level view.  In my experience, as little as five or six crisp PowerPoints slides is sufficient for senior management during a project.  

 

Yes, it is common sense, but it is so easy to get lost in the details.