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How to become a better Regulatory Affairs Strategist?

Have you ever been told that you are a strategic thinker? As a Regulatory Affairs professional, this is one of the qualities that can tremendously improve your career, lead to promotions and new business opportunities. Some people are however struggling with strategic thinking and maybe you even got the feedback that you should be more “strategic”. We usually associate strategic thinking with terms like “big picture”, “high level” but without guidance, especially in a complex field like Regulatory Affairs, it is easy to feel frustrated and discouraged.

Good news is that strategic thinking can be improved, and it is a skill that has the highest return on investment when practiced in your daily work. This skill is not reserved only for the C-suite executives and senior Regulatory Affairs professionals. Everyone can benefit from strategic thinking, even If you are just starting in a Regulatory Affairs field.

So, what are the steps that you can take now to become a better strategic thinker in Regulatory affairs?

1. Think before you act

This seems obvious, however this is the most common mistake many Regulatory Affairs professionals make. Do you remember the time when a Regulatory Agency asked you to provide your feedback and someone from your team immediately started drafting the response or sharing their opinions without taking time for reflection?

If you are “being too busy to think” expect issues that could have been prevented if you slowed down. You need to implement “thinking time” in your daily work. Productivity will also improve as there will be fewer mistakes.

2. Be creative

How many times have you seen that everyone in the meeting room has the same opinion until the strategic thinker, usually after a period of silence, asks few crucial questions and completely changes the strategy that everyone was already prepared to follow blindly? This happens because it is easier to follow “assumptions” and thought patterns than it is to really think about the issue. For example, our day-to-day business in Regulatory Affairs involves constant discussions with Regulatory Agencies on various topics and answering their questions. We have often seen that product teams are by default inclined to accept various requests from agencies, until a strategic thinker challenges this approach and suggests a better solution that either involves better explanation of the topic or provision of other win-win solutions.

This does not mean to be unnecessarily combative and challenge every decision, it is more about understanding the underlying assumptions, how and especially why a certain decision is proffered by the team.

3. Think about the whole organization

Even if you are not a CEO, think about your tasks as a Regulatory Affairs expert and how they influence the overall success of your organization. How are your activities helping your organization to be more successful? Are your yearly, monthly, weekly and daily tasks aligned with the goals of your organization?

For example, when you are asked to provide a Regulatory strategy for registration of a new drug, ask yourself “Why this specific strategy?” and “Is there any other more creative way to get to the same goal?”

Think about the ways in which your skills, knowledge and experience can support other departments and your non-regulatory affairs colleagues.

4. Never stop learning

It is easy to focus only on daily tasks, rely on the SOPs, “on the job training” and knowledge gained within your organization. However, this is not enough. Regulatory Affairs doesn’t exist in vacuum and there is always a reason why things are done in a way they are done.

If in doubt you can always start with a simple “why”. Ask your colleagues this simple question and you will be amazed how much you can learn in a short time period.

Professional industry organizations (DIA, EFPIA, TOPRA, RAPS, etc.) are a great place to start and broaden your horizons.

Attending seminars and conferences is another good idea, as well as enrolling into a professional MSc program.

5. Learn from executives

If you have this opportunity, consider yourself lucky. Not everyone gets a chance to hear and see what good executives are doing and especially “how” are they doing it.

Carefully observe how they react to proposed strategies or solutions, how they challenge the proposed, how they communicate good and bad news and how they treat their peers.

You will quickly notice patterns, especially in a way they communicate and you will hear a lot of “why”.

6. Be deliberate about your choices

The day has a limited number of hours and if you are not careful enough, it is easy to get lost in endless meetings and hundreds of emails.

Some things are more important than others. Think about long term consequences of your decisions. Is this going to be important in a month? How about 6 months or a year? Don’t let things just happen to you, use your time wisely. Even if you think strategically, plan accordingly and ask all “tough and creative questions”, the day still has the same number of hours. Prioritize!

7. Connect the dots

Regulatory Affairs strategists think about connections between ideas, people, plans and opportunities and find new ways to benefit from those connections. Put your thinking cap on, it’s time for deep and focused thinking.

8. Be forward-thinking

As a Regulatory strategist you should help your organization with a clear step-by-step action plan that will lead to a desired outcome. In order to do so, you need to realistically assess the current situation, identify strengths and weaknesses and “future proof” your development program so that the value and benefits can still be expected in the distant future. This scenario planning is definitely not an easy task.

As a Regulatory Affairs expert, the real value in strategic thinking is in becoming a person who is able to act today in a way that will assure long term success while challenging conventional thinking.

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