Senior Manager, Regulatory Affairs

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.

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