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Overview:
- Erasca is seeking a Senior Manager or Associate Director of CMC Regulatory Affairs to lead regulatory activities for clinical trials and future submissions.
- This role reports to the Executive Director and requires an independent, self-directed professional.
Responsibilities:
- Deliver CMC regulatory support through QC review of submission components and preparation of regulatory documents.
- Assess proposed CMC changes and develop global regulatory filing strategies.
- Collaborate on eTMF processes and represent regulatory on study teams.
Qualifications:
- Undergraduate degree required; advanced degree preferred.
- 5+ years of experience in pharmaceutical or biotech regulatory affairs, especially in oncology.
- Strong organizational skills and ability to translate regulatory requirements into practical plans.
Erasca
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.