Head of Regulatory

We're partnering with an innovative clinical-stage biotech developing novel therapies in areas of significant unmet medical need. As early programs move into the clinic, the company is looking for a hands-on regulatory leader to own strategy from the ground up.

The opportunity

• Own regulatory strategy for early-stage programs, from preclinical through first-in-human and beyond
• Serve as the primary point of contact with FDA and other health authorities
• Lead key submissions and meeting packages, such as pre-IND, IND and scientific advice
• Work closely with clinical, CMC and nonclinical teams in a lean, collaborative environment
• Build and scale the regulatory function as programs progress

The profile

• Advanced scientific degree preferred, with progressive regulatory experience in biotech or pharma
• Early development experience, ideally including IND and first-in-human
• Experience in small molecule development and multiple therapeutic areas is a plus
• Comfortable working in a small team or as a team of one at a fast-moving company
• A strategic thinker who's also happy to roll up their sleeves

Why consider

• A leadership role from the ground floor with real visibility and influence
• Meaningful science with the potential to change patients' lives
• Flexible working model

For a confidential conversation, reach out to Sydney Hewitt at EPM Scientific - sydney.hewitt@epmscientific.com