Regulatory Affairs Managers

What the job really is

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

At a glance

• Sector: Management
• O*NET-SOC code: 11-9199
• O*NET job zone: 4 — considerable preparation
• Work sample tasks on file: 12
• Tools and technologies listed: 12

What you actually do

Work sample tasks recorded for this occupation:

• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Provide responses to regulatory agencies regarding product information or issues.
• Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Manage activities such as audits, regulatory agency inspections, or product recalls.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Maintain current knowledge of relevant regulations, including proposed and final rules.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

Tools and technology

Adobe Acrobat, Microsoft Access, Microsoft Excel, Microsoft Office software, Microsoft Outlook, Microsoft PowerPoint, Microsoft Project, Microsoft SharePoint, Microsoft Visio, Microsoft Windows, Microsoft Word, SAP software

What employers expect you to already be comfortable with.

Where this job leads

Related occupations — the usual moves up and sideways:

• Regulatory Affairs Specialists
• Compliance Managers
• Environmental Compliance Inspectors
• Management Analysts
• Clinical Data Managers
• Financial Risk Specialists
• Administrative Services Managers
• Quality Control Systems Managers

Getting in

O*NET assigns this occupation job zone 4 (considerable preparation). The related occupations above are the realistic routes in and out.

Find openings

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Check this against the source

O*NET OnLine: Regulatory Affairs Managers — the authoritative public-domain profile this page is derived from, including the full task list, reported skills and the wage estimates for your region.

Derived and rewritten from the public-domain O*NET database (U.S. Department of Labor / Employment and Training Administration). Figures are observations, not promises — always confirm salary, licensing and visa requirements with the employer and the relevant authority.