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| Median Wage (USD, 2025) | Projected Job Openings (2025-2035) | Projected Growth (2025-2035) | |
|---|---|---|---|
| National Statistics | $80730 | 33300 | 2.9% |
| State Statistics | - | - | - |
| City Statistics | - | - | - |
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: Over 3 months, up to and including 6 months
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.
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, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Coordinate recall or market withdrawal activities as necessary.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Develop regulatory strategies for products.
- Identify relevant guidance documents, international standards, or consensus standards.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Participate in internal or external audits.
- Compile and maintain regulatory documentation databases or systems.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or conduct employee regulatory training.
- Write or update standard operating procedures, work instructions, or policies.
- Develop or track quality metrics.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Recommend adjudication of product complaints.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Work Styles
Innovation
A tendency to be inventive, to be imaginative, and to adopt new perspectives on ways to accomplish work.
Achievement Orientation
Intellectual Curiosity
Tolerance for Ambiguity
Initiative
Adaptability
Self-Confidence
Perseverance
Leadership Orientation
Humility
Sincerity
Empathy
Cooperation
Optimism
Social Orientation
Cautiousness
Attention to Detail
Dependability
Integrity
Stress Tolerance
Self-Control
Data Source: This page includes information from the O*NET 31.0 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.