US based biotech, regulatory affairs leader hire 

Proclinical Staffing our consultant managing the role
Posting date: 06/08/2020

US based biotech, regulatory
affairs leader hire

Case study

We partnered with US based biotech who needed our help to find a new senior member for their regulatory affairs leadership team. Our partner, a growing biotechnology company based in Cambridge, Massachusetts, specializes in developing exosomes, natural vesicles that mediate inter-cellular communication, as both a powerful therapeutic modality and an advanced diagnostic system.

The challenge

The company was looking for a senior regulatory affairs director CMC with a highly specialised RA CMC background. This was due to the need for proven track record of successful new biological entity registrations and a strong understanding of biologics products.

The major challenge as always in the Boston area, is that the marketplace is very competitive and it is hard to keep candidates engaged.

The solution

We put together a shortlist of 8, and after an efficient interview process, a successful candidate was identified as a very strong potential hire. Due to the ongoing Covid-19 pandemic at the time of hire (April 2020) and prior to the final interview, there were some potential issues with remote working arrangements. We immediately stepped in to negotiate a working arrangement on both ends, culminating in an agreement for a 50-50 work arrangement post December 2020. Once the HR director gave an in-principle approval for the remote working arrangement proposal, the hire was quickly made.

This was the first full-time regulatory affairs hire for the organisation following on from the VP of RA as they had a skills gap within the CMC. The company were very serious about the hire and worked efficiently to schedule interviews accordingly in order to expedite the process as quickly as possible which left a very positive impression on the candidate.

The outcome

The candidate we placed had three other opportunities to consider. Thankfully the candidate was highly engaged with the company and was very interested in the science, which helped seal the placement in the company’s favour.

The total time to hire from taking the brief to completion was just three weeks. The successful partnership between us and the organisation with further key hires being secured in analytical science and development.