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The Fountain Group
Regulatory SpecialistThe Fountain Group • Cambridge, MA
Regulatory Specialist

Regulatory Specialist

The Fountain Group • Cambridge, MA
30+ days ago
Salary
$55.00–$75.00 hourly
Job type
  • Temporary
Job description
Details for the position are as follows:
  • 6-month contract to start but may convert to perm depending on performance and team needs. can be extended based on workload.
  • Rate: $55-75 an hour to start depending on experience level
  • Location: Cambridge, MA – hybrid roles must be okay coming onsite 3-4 days a week
Job Description:
  • Support the preparation and management of FDA submissions and templates for onboarding new investigators
  • Respond to regulatory inquiries and contribute to the development of annual reports and compliance documentation
  • Serve as a key liaison between the study team and regulatory affairs, synthesizing complex information to support cross-functional decision-making
  • Manage and coordinate a high volume of collaborative materials, including presentation slide decks and written summaries
Required Skills:
  • Bachelor’s degree required.
  • 4+ years of industry experience.
  • Experience in oncology, rare disease, or drug development is strongly desired and where candidates have been successful in the past.
  • Will work cross-functionally and must be able to represent the study team’s perspective clearly to regulatory stakeholders
  • Organized and able to manage multiple concurrent tasks
  • Familiarity with Microsoft Word, Outlook, Excel, etc.
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Regulatory Specialist • Cambridge, MA

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