Erasca is a clinical-stage precision oncology company driven by a bold mission—to erase cancer. Backed by a16z.
About the role
Reporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Undergraduate degree required, advanced degree preferred, RAC certification a plus
- 6+ years of relevant experience in Regulatory Operations or a closely related field, experience in a small or mid-sized company preferred
- Sound knowledge of drug development strategies and regulations
- Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role preferred
- Hands-on experience with regulatory information management or electronic document management systems and with health authority question and commitment tracking
- Strong project management skills, with the ability to manage strategic deadlines, changing requirements, multiple priorities, and operational risks
More about this role
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.
Reporting to the Chief Regulatory Affairs Officer, the Sr Manager or Associate Director, Regulatory Operations will lead regulatory operations across the portfolio. This individual will build and manage the Regulatory Information Management System, lead submission planning and execution, and establish efficient processes for regulatory records, document management, publishing, and health authority correspondence. The role will work closely with Regulatory Affairs and cross-functional teams to ensure timely, high-quality regulatory submissions.
Note this position can be hybrid in our San Diego or South San Francisco locations or fully...
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