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Regulatory Affairs Specialists

$75,670 Median Wage (2023)

34,400 Projected job openings (2023-2033)

5.40% Projected growth (2023-2033)

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.

Experience Requirements Overview

Job Zone Four: Considerable Preparation Needed
A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Most of these occupations require a four-year bachelor's degree, but some do not.
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.

Education, Training and Experience

Required Level of Education: Bachelor's Degree

Related Work Experience: Over 2 years, up to and including 4 years

On-Site or In-Plant Training: Up to and including 1 month

On-the-Job Training: Over 3 months, up to and including 6 months

Detailed Work Activities

Obtain documentation to authorize activities.
Prepare regulatory or compliance documentation.
Coordinate regulatory documentation activities.
Explain regulations, policies, or procedures.
Examine product information to ensure compliance with regulations.
Advise others on legal or regulatory compliance matters.
Maintain data in information systems or databases.
Evaluate applicable laws and regulations to determine impact on organizational activities.
Train personnel in organizational or compliance procedures.
Update knowledge of legal or regulatory environments.
Examine financial records or processes.
Correspond with customers to answer questions or resolve complaints.
Establish organizational guidelines or policies.
Prepare financial documents.
Oversee business processes.
Monitor business indicators.
Analyze environmental regulations to ensure organizational compliance.
Compile technical information or documentation.
Review documents or materials for compliance with policies or regulations.
Communicate with government agencies.
Investigate system, equipment, or product failures.
Analyze data to identify or resolve operational problems.
Recommend changes or corrective procedures.

Work Values

Achievement

Occupations that satisfy this work value are results oriented and allow employees to use their strongest abilities, giving them a feeling of accomplishment. Corresponding needs are Ability Utilization and Achievement.

Working Conditions

Recognition

Relationships

Support

Independence

Tasks

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.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Recommend changes to company procedures in response to changes in regulations or standards.
Participate in internal or external audits.
Compile and maintain regulatory documentation databases or systems.
Write or update standard operating procedures, work instructions, or policies.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Develop or track quality metrics.
Develop or conduct employee regulatory training.
Recommend adjudication of product complaints.
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.

Work Styles

Achievement/Effort

Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.

Persistence

Initiative

Leadership

Cooperation

Concern for Others

Social Orientation

Self-Control

Stress Tolerance

Adaptability/Flexibility

Dependability

Attention to Detail

Integrity

Independence

Innovation

Analytical Thinking

Data Source: This page includes information from the O*NET 28.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET® is a trademark of USDOL/ETA. This page includes Employment Projections program, Occupational Employment and Wage Statistics program, U.S. Bureau of Labor Statistics.

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