• location: Novato, CA
  • type: Contract
  • salary: $45 - $55 per hour


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Job Title: Analyst, Regulatory Affairs

Job Summary

  • Support the Global Regulatory Policy Team in the following regulatory policy activities:

Job Responsibilities

  • Review and assess recently published global regulatory legislation and policies impacting development of treatments for rare diseases, communicate the impact to management and project teams.
  • Lead teams on generation of comments on draft guidances; proactively provide comments on new regulatory guidances, including working with coalition groups.
  • Actively monitor developments and predict policy changes in the rare disease space.
  • Actively communicate policy priorities, to educate and engage both internal and external stakeholders in building a favorable regulatory policy environment.
  • Provide strategic logistical support for managing policy calendars and deliverables.
  • Develop and manage internal policy publications.
  • Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
  • Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.

Education & Qualifications

  • Master Degree in biology or other life sciences discipline REQUIRED, or advanced degree ( PhD, PharmD)
  • 7+ years experience required
  • Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy
  • Strong verbal and written communication skills
  • Strong project management skills
  • Proficient with computer and standard software programs
  • Organizational skills
  • Communication skills, excellent verbal, written and presentation skills
  • Very strong attention-to-detail combined with ability to see big picture and understand business need
  • Strong collaborative skills, as this position requires close working relationships with both internal and external stakeholders.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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