Regulatory Affairs Specialists
Overview
Salary
Demand
Core Tasks
Technology Skills
Tools Used
Top 10 Knowledge Required
Top 10 Skills
Top 10 Abilities
Top 10 Work Activities
Detailed Work Activities
Work Context
Education
Majors
Interests
Top 10 Work Styles
Work Values
Related Careers
Overview
Job Zone Four: Considerable Preparation Needed
Experience
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.
Education
Most of these occupations require a four-year bachelor's degree, but some do not.
Job Training
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Examples
Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, chemists, art directors, and cost estimators.
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.
Salary Salary
Salary at 10th Percentile: $40K
Salary at 25th Percentile: $52K
Median Salary: $71K
Salary at 75th Percentile: $95K
Salary at 90th Percentile: $115K
Demand
Core 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.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
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.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Recommend changes to company procedures in response to changes in regulations or standards.
Compile and maintain regulatory documentation databases or systems.
Participate in internal or external audits.
Write or update standard operating procedures, work instructions, or policies.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
Develop or track quality metrics.
Develop or conduct employee regulatory training.
Recommend adjudication of product complaints.
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.
Monitor national or international legislation on ozone-depleting substances or global warming.
Obtain clearances for the use of recycled plastics in product packaging.
Technology Skills
Technology
Example
Hot Technology
Tools Used
Tool
Example
Top 10 Knowledge Required
English Language
90%
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government
82%
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Biology
69%
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Administration and Management
68%
Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
Computers and Electronics
68%
Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Clerical
64%
Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
Chemistry
56%
Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
Medicine and Dentistry
56%
Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Communications and Media
53%
Knowledge of media production, communication, and dissemination techniques and methods. This includes alternative ways to inform and entertain via written, oral, and visual media.
Education and Training
52%
Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Top 10 Skills
Active Listening
80%
Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Speaking
80%
Talking to others to convey information effectively.
Writing
80%
Communicating effectively in writing as appropriate for the needs of the audience.
Critical Thinking
78%
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Judgment and Decision Making
78%
Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Reading Comprehension
78%
Understanding written sentences and paragraphs in work related documents.
Complex Problem Solving
75%
Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Systems Analysis
75%
Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Social Perceptiveness
68%
Being aware of others' reactions and understanding why they react as they do.
Time Management
68%
Managing one's own time and the time of others.
Top 10 Abilities
Written Comprehension
85%
The ability to read and understand information and ideas presented in writing.
Written Expression
83%
The ability to communicate information and ideas in writing so others will understand.
Oral Comprehension
80%
The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression
80%
The ability to communicate information and ideas in speaking so others will understand.
Deductive Reasoning
78%
The ability to apply general rules to specific problems to produce answers that make sense.
Inductive Reasoning
78%
The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Problem Sensitivity
78%
The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
Speech Clarity
78%
The ability to speak clearly so others can understand you.
Speech Recognition
75%
The ability to identify and understand the speech of another person.
Information Ordering
73%
The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Top 10 Work Activities
Evaluating Information to Determine Compliance with Standards
93%
Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
Getting Information
92%
Observing, receiving, and otherwise obtaining information from all relevant sources.
Communicating with Supervisors, Peers, or Subordinates
89%
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
Communicating with Persons Outside Organization
86%
Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
Interacting With Computers
85%
Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Interpreting the Meaning of Information for Others
85%
Translating or explaining what information means and how it can be used.
Making Decisions and Solving Problems
85%
Analyzing information and evaluating results to choose the best solution and solve problems.
Updating and Using Relevant Knowledge
84%
Keeping up-to-date technically and applying new knowledge to your job.
Establishing and Maintaining Interpersonal Relationships
83%
Developing constructive and cooperative working relationships with others, and maintaining them over time.
Analyzing Data or Information
81%
Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
Detailed Work Activities
Coordinate regulatory documentation activities.
Obtain documentation to authorize activities.
Prepare regulatory or compliance documentation.
Explain regulations, policies, or procedures.
Evaluate applicable laws and regulations to determine impact on organizational activities.
Oversee business processes.
Advise others on legal or regulatory compliance matters.
Examine product information to ensure compliance with regulations.
Compile technical information or documentation.
Review documents or materials for compliance with policies or regulations.
Communicate with government agencies.
Update knowledge of legal or regulatory environments.
Examine financial records or processes.
Maintain data in information systems or databases.
Establish organizational guidelines or policies.
Prepare financial documents.
Monitor business indicators.
Train personnel in organizational or compliance procedures.
Investigate system, equipment, or product failures.
Analyze data to identify or resolve operational problems.
Recommend changes or corrective procedures.
Analyze environmental regulations to ensure organizational compliance.
Correspond with customers to answer questions or resolve complaints.
Work Context
Electronic Mail
How often do you use electronic mail in this job?
Spend Time Sitting
How much does this job require sitting?
Indoors, Environmentally Controlled
How often does this job require working indoors in environmentally controlled conditions?
Face-to-Face Discussions
How often do you have to have face-to-face discussions with individuals or teams in this job?
Work With Work Group or Team
How important is it to work with others in a group or team in this job?
Telephone
How often do you have telephone conversations in this job?
Contact With Others
How much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it?
Importance of Being Exact or Accurate
How important is being very exact or highly accurate in performing this job?
Importance of Repeating Same Tasks
How important is repeating the same physical activities (e.g., key entry) or mental activities (e.g., checking entries in a ledger) over and over, without stopping, to performing this job?
Freedom to Make Decisions
How much decision making freedom, without supervision, does the job offer?
Education
Majors based on the broader career Compliance Officers
Major
Interests
Conventional
91%
Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
Enterprising
81%
Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.
Investigative
29%
Investigative occupations frequently involve working with ideas, and require an extensive amount of thinking. These occupations can involve searching for facts and figuring out problems mentally.
Realistic
24%
Realistic occupations frequently involve work activities that include practical, hands-on problems and solutions. They often deal with plants, animals, and real-world materials like wood, tools, and machinery. Many of the occupations require working outside, and do not involve a lot of paperwork or working closely with others.
Social
19%
Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.
Artistic
15%
Artistic occupations frequently involve working with forms, designs and patterns. They often require self-expression and the work can be done without following a clear set of rules.
Top 10 Work Styles
Attention to Detail
95%
Job requires being careful about detail and thorough in completing work tasks.
Integrity
92%
Job requires being honest and ethical.
Dependability
87%
Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Cooperation
84%
Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
Analytical Thinking
80%
Job requires analyzing information and using logic to address work-related issues and problems.
Persistence
80%
Job requires persistence in the face of obstacles.
Achievement/Effort
79%
Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.
Stress Tolerance
78%
Job requires accepting criticism and dealing calmly and effectively with high stress situations.
Initiative
77%
Job requires a willingness to take on responsibilities and challenges.
Adaptability/Flexibility
73%
Job requires being open to change (positive or negative) and to considerable variety in the workplace.
Work Values
Independence
67%
Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
Working Conditions
67%
Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
Achievement
62%
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.
Support
62%
Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.
Recognition
58%
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
58%
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.
