Precision Hiring for BLA Success and CMC Impact: Enabling End-to-End Regulatory Excellence

Through a targeted and consultative hiring approach, Barrington James enabled the client to successfully complete their BLA submission with no RTWs on the CMC sections by delivering the precise technical expertise and cultural fit other vendors couldn’t provide.

Client Challenge
When the client approached us, they were facing significant recruitment challenges that were directly impacting their ability to progress with a critical BLA submission. Other vendors had been unable to deliver candidates with the right technical capabilities, leaving key roles unfilled and project timelines at risk.

Critical Hires
The client needed to bring in Technical Writers, DS & DP SMEs, Analytical SMEs, and CMC Experts—all crucial for authoring their BLA. These hires were fundamental to ensuring the accuracy, compliance, and timeliness of their regulatory documentation, ultimately driving the success of the wider business objective: a smooth, on-time BLA submission.

Previous Recruitment Channels
Before partnering with Barrington James, the client had relied on other recruitment agencies and personal networks. However, these routes had not delivered the depth of technical expertise or cultural alignment required for success.

Our Approach
We adopted a consultative and collaborative approach, leveraging our previous experience supporting successful BLA filings and our understanding of the structures those companies used. By utilizing a team of consultants with proven success and strong feedback in similar mandates, we conducted a targeted search and rigorous screening process to identify the right SME profiles.
We also invested time in understanding the client’s technical gaps and cultural requirements, ensuring every shortlisted candidate was aligned not only in skill but also in fit.

The Outcome
Our collaboration enabled the client to successfully submit their BLA with no RTWs on the CMC sections—a significant milestone reflecting both the quality of the hires and the strength of the partnership. Feedback from the client has been exceptionally positive. They now work exclusively with Barrington James for similar hires, have referred us internally across additional business functions, and we are now a preferred vendor across multiple areas. Meeting in person further solidified the relationship, cementing long-term trust and collaboration.