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What Makes a Regulatory Affairs Superstar?

April 24, 2015

by Ben Hobbins

Regulatory affairs superstar speaks at conference
Every day I speak with numerous Regulatory Vice Presidents and Heads of Regulatory Affairs across the world in small to large pharmaceutical companies. Often, they are contacting me as they need to find top talent and have not been able to locate the right calibre of individual on their own. Finding the right person will help their business take off and will strengthen their own career at the same time. When I ask these leaders what kind of person they are looking for, they will often say “a Regulatory superstar”!

Whilst everyone has different ideas about what makes such an individual, the overall consensus is a person that can think outside the box. But what exactly does that mean in the world of regulation? Is this a talent that can be learned or do you have to be born with it?

I decided to ask as many of my senior Regulatory friends as possible and set out on a mission to understand what it would take to become such a star. Before giving you a summary, I would first like to thank all of those who gave up their time and shared their wisdom with me. I truly appreciate your kindness. I know how busy you are. Many of you that I spoke with were in the middle of travelling, sitting on planes ready to take off. You are not just Regulatory stars yourselves but superstar friends!

Whilst I was given countless ideas, here are my top 11 favourite superstar attributes provided by my contacts.

1. Regulatory superstars are not only able to understand and analyse a health authority’s processes, but how individuals within a health authority feel about the issues at hand. After all, contacts within health authorities need to stand in front of their boss to convince them that your submission is valid – empathy and a good relationship are not enough. The health authority will have rules that cannot be broken without an extremely valid reason. A Regulatory superstar understands how to work within this set of rules and achieve good outcomes for everyone involved.

2. Although there is a Regulatory background in place, you are able to come up with new approaches that break potential deadlock and move everything forward. Regulatory superstars are adaptable and flexible; they look at guidelines in an innovative way. They have the capacity to create new Regulatory paths.

3. They are solutions driven and can put together a strong argument. They do not simply back down when a health authority says “no”. This does not mean that they should be aggressive and argue but they should have have the capacity to push back, with intelligent and well formed arguments.

4. Many of the people I spoke to said that in an ideal world, the role of Regulatory affairs professional would be divided between two people: one who is detail orientated with the other being a more outgoing negotiator. Of course many organisations do not have the luxury of this headcount so a superstar encompasses both of these attributes.

5. The characteristics of a superstar need to vary depending on geography. Certainly in Europe, pricing is extremely challenging area so Regulatory professionals need to demonstrate clear value in their propositions.

6. A superstar will be able to read guidelines and interpret where they can deviate. They will also be able to make good scientific arguments. They have the capability to rise to the level of whomever they are asked to deal with within the health authority, regardless of their experience or clinical expertise. A good Regulatory professional will give their contact a succinct amount of data – just the right amount – without thinking that 300% will be more persuasive (think Japanese cuisine versus an all-you-can-eat buffet).

7. Often Regulatory professionals think that development is the most exciting part of the process and find the marketing and market access phase less interesting. Stars care about development and maintenance, the big picture and overall strategy.

8. Great Regulatory people put themselves in everyone’s shoes, including Sales and Marketing. It’s not ‘them versus us’. Many Sales and Marketing people feel that Regulatory people are there to say “no” to their proposals. A star Regulatory professional works with Sales and Marketing to create a presence in the market that works from a Regulatory and a commercial perspective.

9. Stars are articulate individuals with strong communications skills. They are people who can express their thoughts clearly and have excellent persuasive skills. Often, people think this means strong verbal skills, but in many cases, written communication in the form of submissions or email is more common. On the other hand, Regulatory professionals who are still in their early careers may feel more comfortable communicating in writing. Stronger verbal communication skills will often develop later, after professionals have had more exposure to health authority visits.

10. When receiving requests for information, Regulatory professionals may be asked to reply to a very tight deadline and their answer needs to demonstrate a great deal of understanding. Questions must be succinctly answered.

11. The ultimate Regulatory superstar will feel passionately about Regulatory reform, never failing to stay up to date with legislative framework.

Finally, I asked my contacts how they develop their staff as leaders and people managers. One of my favourite answers was that a good manager will develop his people gradually, exposing them to ever more challenging situations with health authorities. Having them shadow a more experienced colleague is very effective.

In summary, Regulatory Affairs professionals are absolutely vital to any organisation. Without them nothing happens. Superstars use clear communication and stay focused on the big picture. With the right raw talent, all the attributes mentioned above can absolutely be developed over time.

Ben Hobbins is a Managing Consultant at Talentmark and an expert in supporting pharmaceutical companies secure senior, global leadership level Regulatory Affairs professionals. He can be reached at ben.hobbins[at]

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