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We’ve been saying we need a seat at the table.  And now we finally have one.  So what next?

As Regulatory partners we’ve been asking to be consulted earlier in the product development cycle and in other business decisions affecting Regulatory Affairs.  Our message has been simple – include us in early strategies and we can help streamline the regulatory process to drive and enhance the quality and efficiency of global business.  Our Regulatory strategies can develop in parallel (instead of sequentially) for many Regulatory pathways and turn obstacles into stagegates when allowed enough lead time.

Over the past years the hard work of Regulatory professionals has paid off and our message has been heard – our seat at the strategy table has been saved and there is often a clear name plate reading “Regulatory Affairs” on signature lines and for board room meetings.

It’s finally happening.  All eyes turn to Regulatory as leaders ask questions about clearance for US market, global registration timelines, and testing hurdles for innovation.  The room falls silent as it’s our turn to say what we’ve been wanting to say, what we’ve been advocating they hear. 

So how do you begin to successfully participate at the table?

I’ve seen many experienced and knowledgeable Regulatory partners fumble at the table when working with cross-functional teams and layered organizational charts.  What follows are tips for ensuring your Regulatory seat remains saved at the table and your input continues to be valued and sought-after early.

1.  Learn how to say “Yes”

In Regulatory it is all too easy to say “No”: 

If all you say is “No” there can develop a tendency to stop asking.  The other troublesome matter with a “No” is that is doesn’t help provide the solutions our partners are craving.  An example is when your Marketing partner approaches you about using a new claim X.  While you may be thinking “No, No, NO!  We can’t claim that!”…what might be more useful to the conversation is saying “Well, we don’t have approval for using that claim but we can use different language like [this] to accomplish the same message.”  The solution is to explain why specific wording doesn’t work and to instead ask about the objective of the claim and help brainstorm about softer or alternative language.

The challenge here is to ask yourself how the request can be turned from a “No” into a “Yes” and sharing that information with your partner.

Working with cross-functional teams has become a standard in today’s med tech environment and our skillset as Regulatory professionals is shifting towards the team environment.  We no longer survive on solid technical writing and deep Regulatory knowledge – but also have to be able to develop and communicate strategies, tactfully assert our expertise, and provide creative solutions.  Communicating your “Yes” and other Regulatory knowledge can be a challenge not easily understood in this team environment until mistakes have already been made.

Early in my career I sat on a cross-functional team where I had developed a Regulatory strategy and was executing against it.  The core team didn’t have visibility to or understand much of the strategy and expressed to upper management that I wasn’t doing my job because they didn’t understand what needed to be done.  The lesson I learned was how strategies sometimes need to be shown in communication – expressed through hurdles, what-ifs, milestones, and resource (time) allocation.  I learned how to read the core team and understand the level of communication needed both to the immediate functional partners and to upper management.

Tips for success with this may include developing a strategy document, corresponding slides, or dashboards that express progress against milestones.  What this speaks to is the project management element of Regulatory within core teams and how we need to participate accordingly.  Consider the dynamic of your team’s communication needs so your partners support your management and progress of the Regulatory element.


3.  Teach them when to ask you and why

Educating your cross-functional partners about top-level Regulatory concepts may help keep your operations compliant and may avoid unnecessary delays in business.  Teaching teams about Regulatory matters, like what would trigger a report to FDA, helps get other functions thinking about needing your input before completing plans. 

One way to manage this is to express an open door policy where you encourage the cross-functional partners to pick your brain about proposed changes and actions.  This enables you to teach them about the important facts you need to make Regulatory decisions and arms them with knowledge to consider for future changes.  Efficient habits can also be built as I’ve seen partners come prepared for my open office hours by bringing drawings and powerpoint slides developed to better explain changes in order to understand Regulatory impact. 

The time has come to progress the conversation as we’ve started to get a seat at the strategic table.  As Regulatory professionals the challenge is now about evolving our tactics to sustain the seat and participate effectively across functional teams and throughout organizational charts.  Let’s keep moving forward with providing the service of Regulatory as we build on the progress of our trail blazing predecessors by expanding the worth of tomorrow’s Regulatory leaders.