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Foundation logo
Foundation

A web3 destination.

Regulatory Affairs Specialist

Location

United States

Posted

14 days ago

Salary

$37 - $57 / hour

Seniority

Senior

Bachelor Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

Regulatory Affairs Specialist

Foundation

• Prepare, review, compile, and support submission of regulatory documents for assigned research IND applications, including initial INDs, annual reports, protocol amendments, information amendments, and safety reports. • Support preparation of non-emergency use single-patient IND submissions. • Review investigator regulatory files and site documentation, including Form FDA 1572s, IRB approvals, and related documents, for accuracy, completeness, and compliance. • Assist with maintaining compliance with applicable regulatory requirements, institutional and departmental policies, FDA regulations and guidance, and GCP guidelines. • Maintain professional growth and development by participating in seminars, workshops, professional affiliations, and other learning opportunities to remain current with regulatory affairs practices. • Ensure compliance with applicable regulatory, departmental, institutional policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.

Job Requirements

  • Bachelor's Degree in scientific discipline, regulatory affairs, or a related field with a minimum of 3-5 years of experience or a Masters/PhD in scientific discipline, regulatory affairs, or a related field with a minimum of 0-2 years of experience.
  • Experience within regulatory affairs or in a related FDA-regulated industry is required
  • Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred
  • Excellent written, editorial and verbal communication skills.
  • Strong organizational skills and demonstrated ability to manage deadlines, competing priorities, and regulatory deliverables in a fast-paced environment.
  • Strong analytical, critical thinking, proofreading, and document review skills.
  • Working knowledge of FDA regulatory requirements and guidance related to INDs.

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

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