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Erasca, Inc.
Erasca, Inc.
51 – 200 कर्मचारी
औषधियाँजैव प्रौद्योगिकीस्वास्थ्य सेवा
Erasca, Inc. is a clinical-stage biotechnology company developing precision oncology medicines for cancers driven by the RAS/MAPK pathway. Its modality-agnostic therapeutic pipeline is designed to target this frequently mutated signaling pathway, with the aim of expanding treatment options for patients across multiple cancer types. Erasca’s work brings together oncology research and drug development as it advances programs toward potential clinical impact.
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कंपनी की नौकरियाँ

Executive Director or VP of Regulatory Affairs

Guide global regulatory strategy for Erasca’s precision oncology medicines, from early development through approval and commercialization. Lead FDA and international health-authority engagement, submissions, and product lifecycle planning.

USसंयुक्त राज्यCAकैलिफ़ोर्निया
$2,75,000 – $3,55,000 / वर्ष
हाइब्रिडपूर्णकालिकलीडआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • Set regulatory strategy for an assigned disease area.
  • Drive global regulatory plans and submissions from pre-IND development through approval, launch, commercialization, and lifecycle management.
  • Represent Regulatory Affairs on program and study teams and in disease-area planning.
  • Build regulatory strategies that make development plans comprehensive and compliant.
  • Lead or contribute to regulatory documents, including INDs, CTAs/IMPDs, DSURs, meeting briefing packages, iPSP/PIPs, NDAs, and sNDAs.
  • Ensure submissions are technically accurate and complete.
  • Represent Regulatory Affairs in business development and due diligence.
  • Review clinical documents for scientific quality and regulatory compliance.
  • Act as the main contact for the FDA and health authorities outside the US.
  • Support timely submission reviews and approvals, and lead discussions on regulatory milestones.
  • Direct regulatory work through staff and cross-functional teams.
  • Support company compliance programs, audits, and inspections with regulatory expertise.
  • Manage external service providers and regulatory consultants.
  • Develop and improve systems and processes that make Regulatory Affairs more efficient.
  • Stay informed about US and international regulations affecting company products and processes.
  • Report to the Chief Regulatory Affairs Officer.

आवश्यकताएँ

  • Bachelor’s degree required; advanced degree preferred.
  • At least 10 years of relevant regulatory affairs experience in pharma or biotech, including extensive global strategy expertise from pre-IND through NDA and post-approval.
  • Demonstrated knowledge and experience in US and EU regulatory affairs, including IND, CTA, CTN, and NDA submissions.
  • Experience leading formal health-authority meetings, such as pre-IND, End-of-Phase, and Scientific Advice discussions.
  • Strong knowledge of FDA and ICH guidelines.
  • Ability to turn regulatory requirements into practical, workable plans.
  • Strong organization and close attention to detail.
  • Effective communication, writing, interpersonal, and influencing skills.
  • Experience leading, mentoring, and developing direct reports.
  • Ability to meet demanding goals and deadlines in a fast-paced setting.
  • Collaborative, proactive approach, with the ability to find and implement creative solutions to complex problems.
  • Curiosity, a strong learning mindset, and commitment to science and patients.
  • NDA submission and product approval experience preferred.
  • Experience with expedited pathways such as Fast Track, Breakthrough Therapy Designation, and PRIME is a plus.

लाभ

  • Annual bonus.
  • Equity grants at hire and annually as options to purchase company stock at a specified future price.
  • Paid time off.
  • Holiday and sick leave.
  • Medical, dental, and vision plans.
  • Short- and long-term disability coverage.
  • Basic and voluntary life and AD&D coverage.
  • Flexible spending accounts, including FSA, HSA, and commuter accounts.
  • Critical illness and accident coverage.
  • Pet insurance.
  • Employee assistance program.
  • 401(k) plan with an Erasca contribution.
  • Employee stock purchase program.
  • Casual, collaborative, and enjoyable work environment.

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