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Regulatory Affairs Specialists

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Regulatory Affairs Specialists

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

Key Competencies
* Attention to Detail
* Integrity
* Dependability
* Cooperation
* Persistence
* Analytical Thinking
* Achievement/Effort
* Stress Tolerance
* Initiative
* Adaptability/Flexibility

Representative Tasks
* Coordinate efforts associated with the preparation of regulatory documents or submissions.
* Coordinate, prepare, or review regulatory submissions for domestic or international projects.
* Prepare or maintain technical files as necessary to obtain and sustain product approval.


Job Family
Business and Financial Operations

Sample Job Titles
Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator, Quality Assurance Documentation Specialist, Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Associate (RA Associate), Regulatory Affairs Consultant (RA Consultant), Regulatory Affairs Coordinator (RA Coordinator), Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Strategist (RA Strategist), Regulatory Analyst, Regulatory Compliance Associate, Regulatory Compliance Specialist, Regulatory Engineer, Regulatory Services Consultant, Regulatory Specialist, Regulatory Submissions Associate, Research Compliance Specialist.