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 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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Undergraduate degree required, advanced degree preferred
- 10+ years of relevant experience in pharma or biotech regulatory affairs required, including deep expertise in global regulatory strategy from pre-IND through NDA and post approval
- Proven knowledge and experience in US and EU regulatory affairs required (e.g., IND, CTA, CTN, NDA) and leading formal interactions with health authorities (e.g., pre IND, End‑of‑Phase, Scientific Advice, etc)
- Experience with NDA submission and product approval preferred
- Experience with expedited programs for serious conditions such as FastTrack, Breakthrough Therapy Designation, PRIME, a plus
- Proven knowledge of FDA and ICH guidelines
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 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.
- 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...
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