O*NET Career Intelligence

Regulatory Affairs Managers

SOC 11-9199.01

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Green Occupation Zone 4 Management

Skills

Knowledge

Job Zone

Yes

Green

Top Skills 8

Reading Comprehension

4.1

Writing

4.0

Speaking

4.0

Active Listening

3.9

Critical Thinking

3.9

Judgment and Decision Making

3.9

Monitoring

3.8

Coordination

3.8

Knowledge Areas 8

Law and Government

4.2

English Language

4.2

Medicine and Dentistry

3.5

Administration and Management

3.5

Biology

3.5

Clerical

3.2

Education and Training

3.1

Chemistry

3.0

Key Tasks

1Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

2Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

3Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

4Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

5Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

Also Known As

Clinical Trials Systems Administrator Global Regulatory Affairs Manager Global Regulatory Affairs Vice President Regulatory Administrator Regulatory Affairs Director Regulatory Affairs Manager Regulatory Affairs Portfolio Leader Regulatory Analyst Regulatory Consultant Regulatory Leader