Exec Director/VP Regulatory Affairs

Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer’s most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide. The name “ Erasca ” has an important embedded meaning: it is a contraction of our audacious hope to “erase cancer” that drives our mission and everything that we do on behalf of patients with cancer. Position Summary: Reporting to the Chief Regulatory Affairs Officer, the Executive Director or VP, Regulatory Affairs will lead regulatory strategy for defined disease area and develop and execute global regulatory strategies and submissions from pre-IND through regulatory approval to launch, commercialization, and product lifecycle management. Note that this position can be hybrid in San Diego, CA or South San Francisco, CA or fully remote anywhere in the United States. Essential Duties and Responsibilities: Represent regulatory on program and study teams and in disease area strategy and planning meetings Working with the team, develop regulatory strategies to ensure development plans are comprehensive and comply with regulatory requirements Lead or support preparation and review of regulatory documents (e.g., IND, CTA/IMPD, DSUR, pre-meeting briefing document, iPSP/PIP, NDA, sNDA), including oversight of regulatory submission