Head of Regulatory
Head of Regulatory Affairs Clinical-stage biotech | Flexible / Remote (US)
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
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