We’re working with a well-established, global biotech in the Boston area that’s continuing to invest heavily in its regulatory function and is looking to bring in a Director-level hire within Regulatory Affairs CMC.
This is a high-impact role where you’ll take ownership of CMC regulatory strategy across both development and commercial programs, operating as the lead for key assets. You’ll be working closely with cross-functional teams across development, manufacturing and quality, playing a central role in driving products through to approval and lifecycle management.
The role offers a strong mix of strategy and execution. You’ll be shaping global CMC regulatory plans across the full product lifecycle, with direct involvement in major submissions such as INDs, BLAs and MAAs. You’ll also support Health Authority interactions, helping guide programs through critical regulatory milestones.
There’s good visibility across the organization, with the opportunity to influence senior stakeholders and contribute to broader program strategy, not just execution. You’ll be expected to anticipate and manage regulatory risks, support change control and compliance activities, and help keep programs on track globally.
They’re looking for someone with a strong background in Regulatory CMC within pharma or biotech, typically around 10+ years, with experience supporting major global submissions. The right person will be comfortable working in a matrixed environment, able to balance strategy with detail, and confident operating across technical and leadership teams.
It’s a strong opportunity for someone looking to step into a visible role with real ownership and impact, working on complex programs within a well-resourced global organization.
