Exec Director/VP Regulatory Affairs

Erasca, a clinical-stage precision oncology company, seeks an Executive Director or VP of Regulatory Affairs to lead regulatory strategy for defined disease areas and execute global regulatory submissions from pre-IND through approval and commercialization, reporting to the Chief Regulatory Affairs Officer.

Responsibilities

• Develop and execute global regulatory strategies and submissions from pre-IND through approval and launch
• Lead preparation and review of regulatory documents (IND, CTA/IMPD, DSUR, NDA, sNDA) for accuracy and completeness
• Serve as primary liaison with FDA and overseas health authorities for timely review and approval discussions
• Represent regulatory affairs on program teams, study teams, and disease area strategy meetings
• Plan and direct regulatory activities through regulatory staff and cross-functional teams

Requirements

• Undergraduate degree required; advanced degree preferred
• 10+ years pharma or biotech regulatory affairs experience including pre-IND through NDA expertise
• Deep knowledge of US and EU regulatory affairs (IND, CTA, CTN, NDA) and health authority interactions
• Proven experience with FDA and ICH guidelines
• Experience leading formal health authority meetings (pre-IND, End-of-Phase, Scientific Advice)
• NDA submission and product approval experience preferred
• Familiarity with expedited programs (FastTrack, Breakthrough Therapy Designation, PRIME) a plus