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Do you have a great Regulatory Affairs team?

February 20, 2018

 

If your organization wants to achieve extraordinary results, it will need an amazing Regulatory team. If it’s serious about creating and retaining it, the upside is unlimited. However, creating this team requires experience, strategic planning and management commitment. The real question is how to create and retain an amazing Regulatory team?

 

A team is not simply a sum of individuals; it has its own dynamic, structure, weaknesses and strengths. It is a living organism.  Some companies try to formally assess their Regulatory team by applying a series of surveys, questionnaires and feedback loops. These are all great tools but they rarely give a realistic and full picture. In many situations, the consequences of not having a great Regulatory team are only seen when it’s too late!

 

Creating a winning Regulatory team requires a clear goal from the start. There are many questions that should be answered before the team is created:

 

  • What are your expectations from this team?

  • Are the members of the team going to have a supportive function in your organization or a leading one?

  • Do you start from scratch and train people or hire experienced Regulatory Affairs professionals?

  • What are your budget and timelines?

  • Are they going to work on one or multiple projects and programmes?

  • What Regulatory Affairs activities this team should cover?

  • What kind of reporting structure you want your Regulatory Affairs team to follow?

 

A great Regulatory Affairs team should be your ultimate ally, regulatory knowledge base and strategic planner.

 

Some of the aspects that your Regulatory Affairs team should cover are:

 

  • Interaction with authorities;

  • Pragmatic implementation of emerging regulation and guidance into a specific situation/product;

  • Strategy creation and continuous monitoring;

  • Integration of various subject matter expertise into a specific company position in different regulatory procedures;

  • Advising other departments on regulatory possibilities, obligations and opportunities

  • Continuous training and knowledge sharing within the department

 

What happens when you treat your Regulatory Affairs team badly?

 

If a good Regulatory Affairs team is treated badly they will never reach their full potential, which in turn could have major consequences to your organisation´s success. Some bad examples include:

  • Treating your Regulatory Affairs team as less important than other teams and showing this publicly;

  • Not taking Regulatory Affairs advice seriously and not understanding what the role of Regulatory Affairs actually is;

  • Constant questioning of the team and their instructions are another common examples of bad treatment.

 

What does your Regulatory Affairs team really need?

 

Your Regulatory team needs autonomy in making decisions and this requires trust.  Without trust you will be second-guessing every decision and it can demoralize the team. However, blind trust can also be dangerous. Untrained and inexperienced Regulatory Affairs team with a bad leadership is a recipe for a disaster. It’s in organization’s best interest to have an experienced and knowledgeable regulatory leader who is also assertive and proactive.

 

Transparency, clear goals and risk awareness are mandatory when dealing with regulatory topics.

 

Also, your Regulatory Affairs team needs visibility and its opinion should be respected and heard by other departments and senior management.

 

Small and big victories should be celebrated and good team spirit should be nurtured.

Mistakes are bound to happen, but the way you react to them will shape your team spirit.

 

Creation of a winning Regulatory Affairs team starts with its selection. Retaining qualified and excellent Regulatory team and a great team spirit is an on-going task, not only for the management but also for the Regulatory professionals themselves.

 

 

 

 

 

 

 

 

 

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