Description
Support Regulatory Affairs by coordinating documentation, submissions, audits, inspections, license renewals, and registrations. Maintain regulatory records and calendars, facilitate cross-functional reviews, communicate routine matters with agencies under direction, and compile and format materials for regulatory submissions.
- • Communicate with regulatory agencies on scheduling, submission status, and routine inquiries under supervision.
- • Coordinate, assemble, and route regulatory submissions for domestic and international projects.
- • Track regulatory rule changes and circulate updates to stakeholders; maintain change logs.
- • Assist with technical review by formatting data and checking completeness and consistency.
- • Coordinate review and approval of promotional materials, labeling, batch records, and test methods for compliance.
- • Compile and maintain regulatory documentation repositories and submission trackers.
- • Schedule and document meetings on regulatory pathways and requirements; capture and track action items.
- • Coordinate cross-functional inputs and timelines for preparation of regulatory documents or submissions.
- • Support determination of required submission types by gathering information and maintaining decision logs.
- • Coordinate logistics for regulatory training and maintain training records and attendance.
- • Maintain a current knowledge calendar of relevant regulations, standards, and guidance documents.
- • Obtain and distribute updated laws, guidelines, or standards to project teams.
- • Support internal and external audits or inspections by managing requests and document control.
- • Draft and assemble responses to agency information requests for review and approval; track commitments.
- • Prepare, update, and archive technical files and registration dossiers with proper version control.
- • Route proposed procedural changes and update templates and forms after approvals.
- • Prepare standard regulatory statements, data packages, and questionnaires for customers; track responses.
- • Support routing and tracking of clinical protocols and study documents to ensure required data are captured.
- • Edit, format, and maintain SOPs, work instructions, and policies; manage periodic reviews and approvals.
- • Coordinate documentation, notifications, and status tracking for recalls or market withdrawals under RA/QA leadership.
- • Compile and report regulatory and quality metrics; maintain submission and inspection KPIs.
- • Coordinate collection, labeling, and shipment of laboratory samples requested by agencies.
- • Log, track, and submit adverse event reports as directed; monitor timelines and acknowledgments.
- • Coordinate packaging waste registrations and reporting; maintain related records.
- • Assist with documentation and permits for hazardous waste handling and shipments in collaboration with EHS.
- • Maintain records and filings related to ozone-depleting substances or applicable equipment.
- • Track agriculture-related filings and post-market obligations, if applicable, and coordinate with subject matter experts.
- • Identify, organize, and maintain master lists of applicable guidance documents and international standards.
- • Provide scheduling, document control, and follow-up support before, during, and after inspections.
- • Log, triage, and route product complaints; track investigations and regulatory reporting status.
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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
