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A web3 destination.
Regulatory Affairs Specialist
Location
United States
Posted
14 days ago
Salary
$37 - $57 / hour
Seniority
Senior
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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