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Regulatory Affairs Specialist
South Portland, ME

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ProKatchers LLC

Regulatory Affairs Associate

Job Description

Prepare, review, and maintain regulatory submissions, dossiers, and compliance documents. Support product registrations, renewals, variations, and post-approval activities. Research regulatory guidelines and assess requirements for assigned products. Coordinate with Quality, R D, Manufacturing, and other teams for timely submissions. Track regulatory timelines, authority queries, approvals, and submission records. Overview Industry
  • HR Staffing & Recruitment Firms / Employment Agency / Background
  • Reference Check Firms Job Role
  • Regulatory Affairs Associate Employment type
  • Full Time
  • On Contract Work Mode
  • In Office Qualifications Any Graduate
  • Any Specialization Any Post Graduate
  • Any Specialization Any Doctorate
  • Any Specialization Job Related Keywords Regulatory Affairs Regulatory Submissions Compliance CTD/eCTD Product Registration Lifecycle Management Regulatory Documentation Health Authorities