Regulatory Affairs Analyst

Job Summary

Seeking a Regulatory Affairs Business Analyst, the full-time position offers a remote work option with a preference for candidates local to Cambridge, MA, and focuses on heavy data migration while requiring knowledge of regulatory, publishing, or EDMS models.

Key responsibilities

• Manage data migration processes while ensuring compliance with regulatory standards
• Collaborate with business users, IT groups, and project managers to facilitate effective communication and project execution
• Utilize business analysis techniques and tools to support system development life cycle (SDLC) initiatives

Required qualifications

• 5+ years of experience as a business analyst with expertise in business analysis techniques and SDLC methodologies
• Strong understanding of GxP, CFR 21 Part 11, and systems validation
• Experience in the Life Sciences, Biotech, or pharmaceutical industry is preferred
• Education: BA or BS degree required
• Familiarity with Regulatory and/or Parexel Insight Manager is a plus