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 opportunityOwn regulatory strategy for early-stage programs, from preclinical through first-in-human and beyondServe as the primary point of contact with FDA and other health authoritiesLead key submissions and meeting packages, such as pre-IND, IND and scientific adviceWork closely with clinical, CMC and nonclinical teams in a lean, collaborative environmentBuild and scale the regulatory function as programs progressThe profileAdvanced scientific degree preferred, with progressive regulatory experience in biotech or pharmaEarly development experience, ideally including IND and first-in-humanExperience in small molecule development and multiple therapeutic areas is a plusComfortable working in a small team or as a team of one at a fast-moving companyA strategic thinker who's also happy to roll up their sleevesWhy considerA leadership role from the ground floor with real visibility and influenceMeaningful science with the potential to change patients' livesFlexible working modelFor a confidential conversation, reach out to Sydney Hewitt at EPM Scientific - sydney.hewitt@epmscientific.com