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

Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.

Recognition

Occupations that satisfy this work value offer advancement, potential for leadership, and are often considered prestigious. Corresponding needs are Advancement, Authority, Recognition and Social Status.

Relationships

Occupations that satisfy this work value allow employees to provide service to others and work with co-workers in a friendly non-competitive environment. Corresponding needs are Co-workers, Moral Values and Social Service.

Support

Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.

Independence

Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.

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.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Monitor national or international legislation on ozone-depleting substances or global warming.

Work Styles

Integrity

Job requires being honest and ethical.

Achievement/Effort

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

Persistence

Job requires persistence in the face of obstacles.

Initiative

Job requires a willingness to take on responsibilities and challenges.

Leadership

Job requires a willingness to lead, take charge, and offer opinions and direction.

Cooperation

Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.

Concern for Others

Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job.

Social Orientation

Job requires preferring to work with others rather than alone, and being personally connected with others on the job.

Self-Control

Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.

Stress Tolerance

Job requires accepting criticism and dealing calmly and effectively with high-stress situations.

Adaptability/Flexibility

Job requires being open to change (positive or negative) and to considerable variety in the workplace.

Dependability

Job requires being reliable, responsible, and dependable, and fulfilling obligations.

Attention to Detail

Job requires being careful about detail and thorough in completing work tasks.

Independence

Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done.

Innovation

Job requires creativity and alternative thinking to develop new ideas for and answers to work-related problems.

Analytical Thinking

Job requires analyzing information and using logic to address work-related issues and problems.

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.