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13-1041.07 · Task explorer

Regulatory Affairs Specialists: reported tasks and exploration worksheet

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.

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This source lists 30 tasks, including 25 marked Core and 5 marked Supplemental. Labels and dates are retained below. Employers can combine or divide these responsibilities differently; explore the task itself before assuming it belongs in every version of the role.

Task source dates: 08/2026.

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30 tasks shown

Core · Task 18048 · 08/2026 · Occupational Expert

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

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Core · Task 18045 · 08/2026 · Occupational Expert

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

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Core · Task 18058 · 08/2026 · Occupational Expert

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

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Core · Task 18070 · 08/2026 · Occupational Expert

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

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Core · Task 18054 · 08/2026 · Occupational Expert

Coordinate efforts associated with the preparation of regulatory documents or submissions.

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Core · Task 18061 · 08/2026 · Occupational Expert

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

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Core · Task 18055 · 08/2026 · Occupational Expert

Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

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Core · Task 18062 · 08/2026 · Occupational Expert

Prepare or maintain technical files as necessary to obtain and sustain product approval.

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Core · Task 18067 · 08/2026 · Occupational Expert

Coordinate recall or market withdrawal activities as necessary.

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Core · Task 21095 · 08/2026 · Occupational Expert

Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.

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Core · Task 24014 · 08/2026 · Occupational Expert

Develop regulatory strategies for products.

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Core · Task 21094 · 08/2026 · Occupational Expert

Identify relevant guidance documents, international standards, or consensus standards.

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Core · Task 18052 · 08/2026 · Occupational Expert

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

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Core · Task 18049 · 08/2026 · Occupational Expert

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

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Core · Task 18050 · 08/2026 · Occupational Expert

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

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Core · Task 18051 · 08/2026 · Occupational Expert

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

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Core · Task 18065 · 08/2026 · Occupational Expert

Review clinical protocols to ensure collection of data needed for regulatory submissions.

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Core · Task 18060 · 08/2026 · Occupational Expert

Participate in internal or external audits.

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Core · Task 18053 · 08/2026 · Occupational Expert

Compile and maintain regulatory documentation databases or systems.

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Core · Task 18063 · 08/2026 · Occupational Expert

Recommend changes to company procedures in response to changes in regulations or standards.

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Core · Task 18059 · 08/2026 · Occupational Expert

Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

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Core · Task 18056 · 08/2026 · Occupational Expert

Develop or conduct employee regulatory training.

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Core · Task 18066 · 08/2026 · Occupational Expert

Write or update standard operating procedures, work instructions, or policies.

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Core · Task 18068 · 08/2026 · Occupational Expert

Develop or track quality metrics.

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Core · Task 18064 · 08/2026 · Occupational Expert

Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

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Supplemental · Task 21096 · 08/2026 · Occupational Expert

Recommend adjudication of product complaints.

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Supplemental · Task 19554 · 08/2026 · Occupational Expert

Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

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Supplemental · Task 19553 · 08/2026 · Occupational Expert

Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.

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Supplemental · Task 19552 · 08/2026 · Occupational Expert

Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.

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Supplemental · Task 18069 · 08/2026 · Occupational Expert

Direct the collection and preparation of laboratory samples as requested by regulatory agencies.

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Source and practice material

Occupational context uses the O*NET® 31.0 Database from the U.S. Department of Labor, Employment and Training Administration, under CC BY 4.0. View the occupation.

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