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Evaluating expertise in orphan drug regulatory affairs!

Identifying professionals with regulatory affairs experience is a relatively straight forward exercise when recruiting. However, identifying candidates with exactly the right experience and broader capabilities is a far more complex task. There is a perception that during a time when companies are restructuring and reducing staff numbers, that recruiting good people gets easier. It does not.
During these hard economic times, companies should be looking to maintain a consistently high standard for recruitment, not allowing the bar to be lowered in any incremental way which might reduce the long-term competitiveness of your organisation. If anything, you should always be seeking to raise the bar and drive up recruiting standards, for in difficult competitive times it will be this which differentiates your company and builds skills and prosperity for the future.

So why is this relevant to orphan drugs. Well, the recruitment of regulatory staff remains among the most challenging the sector faces. Within this function, we have seen increasing focus towards identifying professionals with very particular expertise in particular branches of the discipline. We have seen knowledge of therapy areas become more critical in hiring, alongside procedure or regional expertise. Now, with such a dramatic climb in the number of companies working towards orphan drug designations, finding regulatory professionals who possess all the previous qualities as well as knowledge of the specific regulatory environment that governs orphan drugs, is proving a real challenge for corporations.

You have to make sure that your recruitment structure is designed effectively enough to be able to ensure you are assessing this knowledge to the highest possible level. Every company is constrained by resources and utilising management time to assess these capabilities is highly inefficient and expensive. Make sure your recruitment organisation, whether internal or external, can properly evaluate this type of expertise and make sure you are getting the very highest quality regulatory professionals you can hope to attain.

It is sometimes very important to fight for the talent you want. Most leaders are judged by the performance of their organisations. A performance which is largely defined by the skills and experience needed to deliver it. Having the standard of talent which defines your organisation, and therefore you, compromised by ineffective recruitment procedure is fundamentally at odds with the objectives you are asked to deliver. This is something which is well understood by top leaders, as they frequently attribute their success to the people they have managed to surround themselves with. So push for the best you can, drive the organisation to aim incredibly high, however politically difficult that can sometimes prove.

What is clear to us at Liftstream is that we constantly have to increase and deepen our knowledge of the many facets of regulatory affairs to be able to ensure we are providing our clients with good regulatory talent. We also have to make assessments of the orphan drug or rare diseases knowledge to make sure clients in this area can access the highest quality expertise. All of this has to be coupled with extensive and proactive recruitment activities. Yet, rigorous assessment is what brings the most value, for it ensures your recruitment standards remain high, both now and for the future, because good people demand to work with other good people.

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