Crinetics Pharmaceuticals

Discovering drugs for endocrine diseases and endocrine-related tumors. #acromegaly #crinetics #CarcinoidSyndrome

Manager, Regulatory Submission

ComplianceComplianceFull TimeRemoteTeam 201-500Since 2015H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

33 days ago

Salary

$110K - $136K / year

Bachelor Degree8 yrs expEnglish

Job Description

• Manage submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities • Participate in submission team meetings • Coordinate multiple concurrent interrelated activities for submission projects for products in the delivery of published submissions within required timelines • Anticipate obstacles and develop solutions within the team • Coordinate submission publishing with publishers and provides notification to ensure all required resources are available to meet submission timelines • Prepare content planner for publishing and work with team members to resolve publishing issues • May perform publishing tasks • Assist with team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances

Job Requirements

  • Bachelor’s degree
  • Minimum 8 years of relevant experience in the biotech or pharmaceutical industry
  • Minimum 2 years of experience working with submission content planning
  • Strong working knowledge of regulatory submission publishing standards and procedures including word processing and regulatory publishing software
  • Preferred: Experience working with Veeva RIM document management system
  • Experience working with LORENZ docuBridge FIVE
  • Experience working with Accenture StartingPoint
  • Utilizing Smartsheet for submission content planning
  • Experience producing eCTD U.S. and MAA submission

Benefits

  • Discretionary annual target bonus
  • Stock options
  • ESPP
  • 401k match
  • Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
  • 20 days of PTO
  • 10 paid holidays
  • Winter company shutdown

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