O*NET Career Intelligence

Regulatory Affairs Specialists

SOC 13-1041.07

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.

Green Occupation Zone 4 Business and Financial Operations

Skills

Knowledge

Job Zone

Yes

Green

Top Skills 8

Reading Comprehension

4.1

Writing

3.9

Critical Thinking

3.9

Speaking

3.8

Active Listening

3.6

Complex Problem Solving

3.6

Judgment and Decision Making

3.6

Systems Analysis

3.6

Knowledge Areas 8

English Language

4.4

Law and Government

4.2

Clerical

3.2

Computers and Electronics

2.9

Administration and Management

2.9

Medicine and Dentistry

2.8

Mathematics

2.7

Biology

2.7

Key Tasks

1Coordinate, prepare, or review regulatory submissions for domestic or international projects.

2Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

3Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.

4Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

5Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Also Known As

Clinical Quality Assurance Associate Clinical Quality Assurance Specialist Compliance Analyst Compliance Consultant Compliance Specialist Drug Regulatory Affairs Specialist Product Safety Specialist Quality Assurance Documentation Coordinator Quality Assurance Documentation Specialist Quality Assurance Specialist