I’m working with an innovative, growing biotech who are looking to bring in a Senior Manager, Regulatory Affairs to support their clinical-stage pipeline.
This is a hands-on role in a lean environment, ideal for someone who enjoys working close to the science and taking ownership across both strategy and execution. You’ll be supporting global regulatory activities across early to mid-stage development programs, working cross-functionally with CMC, clinical, and non-clinical teams.
What you’ll be doing:
* Supporting and contributing to global regulatory strategy
* Preparing and managing regulatory submissions (INDs, CTAs, amendments)
* Working closely with internal teams and external partners to ensure alignment across development activities
* Supporting interactions with health authorities across the US, UK, and EU
* Providing regulatory input into study design, protocols, and development plans
* Tracking regulatory requirements and supporting compliance activities
What they’re looking for:
* Experience in Regulatory Affairs within biotech/pharma
* Strong exposure to clinical trial applications and regulatory submissions
* Understanding across CMC, clinical, and non-clinical components
* Ability to work independently and manage multiple priorities
* Comfortable in a fast-paced, evolving environment
Experience in advanced therapies, biologics, or complex products would be beneficial, but not essential.
This is a great opportunity to join a small, high-impact team where you’ll have real visibility and ownership.