Regulatory Affairs Specialists

What the job really is

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.

At a glance

• Sector: Business & Financial
• O*NET-SOC code: 13-1041
• 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:

• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Coordinate recall or market withdrawal activities as necessary.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Identify relevant guidance documents, international standards, or consensus standards.

Tools and technology

Adobe Acrobat, Microsoft Access, Microsoft Excel, Microsoft Office software, Microsoft Outlook, Microsoft PowerPoint, Microsoft Project, Microsoft SQL Server, Microsoft SharePoint, Microsoft Visio, Microsoft Visual Basic, Microsoft Word

What employers expect you to already be comfortable with.

Where this job leads

Related occupations — the usual moves up and sideways:

• Coroners
• Regulatory Affairs Managers
• Compliance Managers
• Environmental Compliance Inspectors
• Government Property Inspectors and Investigators
• Compliance Officers
• Quality Control Systems Managers
• Document Management Specialists

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 Specialists — 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.