Small Phase 2 pharma pursuing oncology, stroke and potentially cerebral palsy indications. Need expert regulatory strategy part time but long term. 20 hours a month to start with variation expected. 2023 is a critical year for regulatory strategy- currently running a phase 2, sponsor had tried for a phase 2b transformation trial but FDA requested they stay with phase 2. Most likely will run a PK study due to FDA inquiries. Potential to seek fast track in 2023. Interest in European agency, might pursue study/approval pathway, particularly in the UK.
Required is a regulatory strategist with expertise in all relevant FDA guidance including fast track, as well as UK regulatory approval pathway experience, agency behavior and current thinking, ability to interact effectively with FDA and internal stakeholders, attend FDA meetings, oversee regulatory filings, perform regulatory writing as needed. It is particularly helpful if the expert understands the small pharma connections between regulatory compliance, small pharma funding needs, and bringing new, safe and effective medicines to patients who need them.