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5 Regulatory Affairs success habits to start practicing right away

September 18, 2017

When I was starting in Regulatory Affairs I was lucky enough to have great tutors who thought me first-hand some basics principles of our industry. As I gained more experience within Regulatory Affairs and started applying those principles, I saw a tremendous improvement in my ability to resolve conflicts, successfully complete tasks at hand and reach agreements.

 

Throughout my Regulatory Affairs career I have been working with a number of industry professionals in all phases of drug development including my beloved Regulatory Affairs colleagues. By carefully observing the ways my seniors dealt with difficult topics I have noticed that almost all of them practice the same principles I was thought:

 

1. Get into science

 

You must know inside-out the product you are dealing with.

 

Get familiar with all relevant scientific and regulatory guidelines for the region you are targeting. Read thoroughly and frequently the Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD) and Clinical Study Protocols if the product is not yet on the market (i.e. it is still in the development phase) and eCTD Module 2 documents for products that are already on the market. These documents give the best summary information about the product. This will help you fuse scientific topics of discussion into the overall drug development strategy and will properly equip you to make better-informed judgments.

 

Further, talk to your colleagues to give you insights into aspects that might not be written inside these documents (e.g. historical strategy decisions, current positions on future development, etc.).

 

Don’t be afraid to ask your Subject Matter Experts on any scientific point you struggle with- they are usually happy to explain it.

 

2. Be present

 

Invisibility is good if you are a magician but as a Regulatory Affairs professional you must be present. In today’s way of working where people are increasingly opting for alternative working set-ups (e.g. working from home, working part-time or often traveling) it is extremely important to maintain the control and ownership over the project.  No matter where you are (in the office, working from home or on a business trip) people should be able to reach you and should be assured that you are following up on your tasks regularly and in a timely manner.

 

Don’t miss out on important team meetings and, if you do, be sure to swiftly follow-up with the meeting organizer on any action points assigned to you.

 

Respond swiftly to emails, SMSs and missed calls.

 

3. Listen more, talk less

 

Who doesn’t want to talk more instead of listening to others?

 

Talking to others is much more enjoyable than listening to their stories. Our regular working days are filled up with numerous meetings where we discuss different topics and we often feel that we must comment on every single point and that the person talking the most is the winner of the meeting.

 

But, talking less will give you couple of benefits:

  • The person you listen to will feel better understood when you only listen (with no interruption or comments in-between)

  • You will be receiving information, allowing yourself to process it properly

  • You are less likely to give a wrong information

  • People will look forward to what you have to say after a long listening phase

 

We, as Regulatory Affairs, particularly benefit from this skill since we are often the ones coordinating complex submissions requiring a lot of people to be involved. By carefully listening to them you will be able to gather valuable information to make good decisions.

 

Funny enough, people usually perceive persons who mostly listen to them as more considerate and as better communicators. However, this skill must be learned and gets better with everyday practice.

 

If you start practicing this skill I am sure you will notice some positive changes around you.

 

4. Complain less

 

When you complain you position yourself as a victim and you feel out of control. Your team members and/or your boss feel that as well.

 

If you have any particular problem you should bring it up to your boss or to your team members. You should try to solve it as soon as possible.

 

Complaining that your safety manager doesn’t reply to your emails wouldn’t resolve the situation. You are better off calling that person and trying to help him/her in sorting out the issue. Both you and that person will feel better. But do not just complain about it.

 

People don’t want to listen to complainers and tend to avoid them.

 

5. Get the job done

 

Related to the above point: stop complaining and GET THE JOB DONE. Everybody loves doers and avoids complainers.

 

If your boss or your team gives you a task try to get it done with as little questions as possible, and, if possible, earlier than planned. You will feel great about yourself and your boss/team will be delighted. Everybody will love to work with you and fell a great loss if you are not there.

 

 

Do you have some other success habits to add? Please share your thoughts with us!

 

 

 

 

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