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Daily challenges of Regulatory Affairs Experts and how to overcome them

Let’s be honest, the number of tasks a typical Regulatory Affairs manager is asked to perform during a week can be brutal. Meetings, calls, coaching, submissions, preparation of responses, team management and hundreds of emails all contribute to the feeling of never-ending daily grind.

Without effective ways to manage one’s time during the course of every day, week, month and year, a Regulatory Affairs professional cannot and will not be successful.

The best Regulatory Affairs colleagues (and not only Regulatory Affairs) that I personally know are extremely good organized and true time management experts. These are some tips that helped them become better Regulatory experts:

Know your priorities

Write down your tasks for the upcoming day. If you are as busy as I am, you probably have more than 10, which is usually the case with many Regulatory Affairs professionals.

However, the challenge with this kind of to-do-list is that many people can’t finish all tasks and rarely even pay attention to the list once the daily activities start.

What I find helpful is to group tasks and laser-focus on those that really make the difference and are a “must”.

You need to identify your top priorities each day. Activities like preparation of responses to authority questions, SmPC/PIL updates, strategy discussions and high-impact document updates (PIPs, Module 2 documents, Briefing books for scientific advice, etc.) are usually extremely important to me and from my experience they made the biggest impact in my career so far. Identify your top priorities and hold yourself accountable to completing them.

Perfect is the enemy of the good

Voltaire was an influential French enlightenment writer, historian and philosopher who used to say, “The best is the enemy of the good.” Luckily for us, he was right.

Many high achieving Regulatory Affairs professionals are perfectionists, nothing wrong with that. The challenge is to identify the tasks that should be “good enough”. Many customers, including your boss, would rather see you deliver good strategy, proposal, plan and any important activity today than the “perfect one” in two weeks. For example, preparing answers to authority questions is a time-limited activity (sometimes limited to 24-hours) and requires a “good enough” approach in compiling a satisfactory response.

Perfectionism is what drives many people to do remarkable things and there is nothing wrong about it. But it has a dark side, too. Some challenges are already so hard, and the additional challenge of "perfection" can intimidate people so they don't even try or they procrastinate.

Don’t get too comfortable

When you were starting out as a Regulatory Affairs professional, everything was new, strange and complicated. New abbreviations, endless regulation and it probably took some time until you developed your Regulatory Affairs “worldview”, being comfortable with your skill level, knowledge and experience.

If you were put on the projects aligned with your strengths and previous experience your daily work can become less challenging, maybe even easy. Avoid this at all costs. Actively seek new challenges that make you feel slightly out of your comfort zone. That is where growth happens.

What are your must-use tips for Regulatory Affairs professionals? Feel free to share them with us.

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