Description
Support the coordination and documentation of regulatory activities, including audits, inspections, license renewals, registrations, and submission preparation. Compile, organize, and track materials for regulatory filings and maintain accurate records to ensure compliance.
- • Review labeling, packaging, and promotional materials for compliance under guidance.
- • Assist in coordinating and preparing regulatory submissions for domestic and international projects.
- • Compile, format, and organize data and reports for inclusion in submissions.
- • Maintain regulatory documentation databases and document control systems.
- • Track submission timelines, milestones, and agency correspondence.
- • Draft routine communications to regulatory agencies and coordinate follow-up under supervision.
- • Support internal audits and external inspections, including logistics and document retrieval.
- • Prepare inspection readiness materials and assist with post-inspection responses.
- • Maintain technical files and product registration dossiers to sustain approvals.
- • Monitor and summarize changes to regulations, standards, and guidance documents.
- • Distribute regulatory updates and support updates to SOPs, work instructions, and forms.
- • Coordinate cross-functional reviews of regulatory documents and collect approvals.
- • Assist in determining required submission types or internal documentation for product or labeling changes.
- • Prepare responses to customer regulatory inquiries, surveys, and questionnaires.
- • Support clinical and nonclinical teams by checking protocols and reports for regulatory content requirements.
- • Help develop and track regulatory and quality metrics and dashboards.
- • Coordinate license renewals, registrations, and certifications, ensuring timely payment and filings.
- • Assist with recall, field action, or market withdrawal logistics under direction.
- • Organize and archive agency communications, commitments, and decision letters.
- • Identify applicable guidance documents, international standards, and consensus standards.
- • Support employee regulatory training by preparing materials and tracking attendance.
- • Assist with adverse event reporting workflows by gathering information and drafting reports under supervision.
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Management & Entrepreneurship
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026
