Is your asset pre-clinical, and do you want to set up Regulatory from the get-go?
Maybe clinical development has progressed with consultancy support so far?
Or perhaps you're into Phase 2 or 3, and it's time to bring Regulatory in-house?
If it's time to make your first hire in Regulatory Affairs, here are some key considerations:
Consultant Vs. Permanent hire
Do you have enough work for a full-time permanent employee? Especially at pre-clinical stages, week to week you may not. The last thing you want is to pay a senior expert only for them to be under-utilised, and potentially a little bored!
Flexible consultancy support is the natural choice in this instance. However, many businesses prefer a senior Regulatory hire to be more formally committed and ensure a long-term relationship.
Bear in mind too, that IR35 regulations can mean consultants are restricted in the decision-making process.
Have you considered hiring a permanent employee for part-time hours? Would you then allow them the flexibility to do other (non-competing) work in their free time?
Overall, it's about finding the best person for the job.
Are you looking for a VP-level Head of Regulatory? Or could a Director level candidate step up into the role? Or maybe it's a hands-on Regulatory Manager who will make the biggest difference, with senior input coming from external suppliers?
Budget constraints often see small businesses consider less experienced and therefore less expensive candidates, but who can still contribute the correct level of Regulatory input required at each development phase.
Do you need them to come from a strong clinical background, or be a CMC expert? Reviewing the other capabilities in your leadership team, you might be able to bring in the missing expertise.
Often though, a generalist with an all-round overview of clinical and non-clinical Regulatory strategy may be your best bet. They will likely need to draw on the support of specialist consultants, so someone with a strong network will be beneficial.
If you're working in a niche Therapeutic area like Oncology or Cell&Gene Therapy, then specific knowledge of these areas will be a key consideration. Likewise, if you plan to develop for the US or EU market, you will need someone who has relevant FDA or EMA interactions under their belt.
What are your priorities? Thinking ahead over the next 3-5 years, where do you envisage your development taking you? Will you be commercialising yourselves, and therefore seek a candidate who has delivered MAAs? Or is out-licencing the route for you, in which case someone who has been part of licensing deals may be better suited?
If you're far enough into development, the chances are you will have outsourced to an individual or team of consultants thus far. Whoever joins to head up Regulatory Affairs must be able to build a strong relationship with existing partners. Or, if they will be your solo Regulatory representative, they will rely on consultants in the future, so need to get the best out of them.
If you are planning to build a Regulatory Affairs team, do the candidates you're meeting have the managerial capabilities you need, plus the desire to build an environment that fosters collaboration and progress? Personality and Culture Add is key. At a senior level, this person will embody your culture, inspire the team, and enhance the brand. Do their values and personality align?
What should you pay them?
With this amount of incredible scientific development going on in the UK, naturally, every company thinks their pipeline is the best, and that candidates will be lining up to work for them. But it's tough to secure top-level candidates, who are in high demand! Are you offering a competitive package that will attract and retain the correct level of candidate? RBW can provide market intelligence to help you understand the landscape.
How will you find them?
Candidates at this level are typically not applying for positions via adverts. Use your network of connections, and consider reaching out to a specialised consultant to search for you.
RBW provides strategic consultancy to advise and guide throughout the process. We love consulting with small biotech firms to define needs, deliver searches, and build teams.
Have you been involved in finding a first hire in Regulatory? If you think of anything else you had to consider, please get in touch - Katie.Dunbar@rbwconsulting.com