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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

Senior Manager or Associate Director, Regulatory Operations

Lead regulatory operations and submissions at Erasca, a clinical-stage precision oncology company. Oversee regulatory systems, documentation, health authority correspondence, and cross-functional submission delivery.

USसंयुक्त राज्यCAकैलिफ़ोर्निया
$1,85,000 – $2,00,000 / वर्ष
हाइब्रिडपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • Oversee regulatory operations across the company’s portfolio.
  • Develop and manage the Regulatory Information Management System.
  • Plan and direct regulatory submission execution.
  • Create efficient workflows for regulatory records, document management, publishing, and health authority correspondence.
  • Coordinate with Regulatory Affairs and cross-functional teams to deliver timely, high-quality submissions.
  • Work with Regulatory Leads and stakeholders to set submission content, ownership, schedules, and deliverables.
  • Monitor progress, surface risks and dependencies, and move submission work through completion.
  • Lead or coordinate routine submissions, including DSURs and IBs.
  • Keep submission records, correspondence, commitments, regulatory information, and related trackers accurate.
  • Assist with regular quality reviews of study TMFs and close documentation gaps.
  • Create and maintain document templates, formatting rules, naming conventions, submission-ready standards, and archiving practices.
  • Keep regulatory repositories and archives organized and ready for inspection.
  • Assist with or oversee the Regulatory department budget, including forecasts, invoices, and payment approvals.
  • Carry out responsibilities in line with company values, policies, and applicable regulations.

आवश्यकताएँ

  • Bachelor’s degree required; an advanced degree is preferred, and RAC certification is a plus.
  • At least six years of relevant experience in Regulatory Operations or a related field.
  • Solid understanding of drug development strategies and regulations.
  • Experience supporting or preparing a marketing application (NDA/BLA/MAA) or major amendment in a lead operational role is preferred.
  • Practical experience with regulatory information management or electronic document management systems, including tracking health authority questions and commitments.
  • Strong project management skills, including handling strategic deadlines, shifting requirements, competing priorities, and operational risks.
  • Experience formatting documents and creating authoring templates.
  • Experience training colleagues in business processes, RIM or EDMS practices, and submission standards.
  • Experience building operational dashboards or portfolio reports using Smartsheet, Microsoft 365, or similar tools.
  • Ability to learn quickly, solve technical problems, and lead change.
  • Ability to work in an entrepreneurial, fast-moving, dynamic, team-focused environment.
  • Curiosity, a strong learning mindset, and commitment to science and patients.

लाभ

  • Annual bonus.
  • Equity grant upon hiring and annually, as an option to purchase stock in the future.
  • 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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