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Regulatory Affairs Specialists
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Description: what do they do?
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.
Also known as:
Regulatory Affairs Strategist (RA Strategist), Regulatory Engineer, Regulatory Services Consultant, Drug Regulatory Affairs Specialist, Regulatory Affairs Associate (RA Associate), Regulatory Specialist, Regulatory Affairs Specialist (RA Specialist), Regulatory Affairs Analyst (RA Analyst), Regulatory Affairs Consultant (RA Consultant), Regulatory Submissions Associate

    What does this information tell me?

    This description is a quick overview of what workers in this career might do.

    "Also known as" shows other common names for this career.

    What is the source of this information?

    This information comes from an O*NET database. Learn more on the Help page.

Outlook: will there be jobs?
Image. Employment outlook for this occupation
New job opportunities are likely in the future.


    What does this information tell me?

    Outlook information can tell you whether a career is expected to be in demand in the future—that is, whether there are likely to be job openings if you choose this career. Careers can have one of three outlooks:

    • A Bright outlook means new job opportunities are very likely in the future
    • An Average outlook means that a small number of new job opportunities are likely in the future (less than an 8 percent increase)
    • A Below Average outlook means new job opportunities are less likely in the future

    You can also view local job listings in this field by clicking "Find job openings" above. This can help you see if local businesses are hiring—another way of looking at demand.

    What is the source of this information?

    This information comes from O*NET Bright Outlook occupations, 2019. Note this information is only available at a national level, so even if you selected a state, you’ll only see this information for the whole country.

Projected employment
United States
319,900
2018 Employment
338,500
2028 Employment
6%
Percent change
30,700
Annual projected job openings
You’re seeing projected employment information for Compliance officers because we don’t have information for Regulatory Affairs Specialists.

    What does this information tell me?

    Projected employment shows how much employment is expected to grow in this occupation over a 10-year period. This can help you decide if this career is a good choice for future job opportunities. You can look at projected employment in your state, or in other states where you might consider living.

    You can see the total number of people employed in this occupation in 2016 (for states) or 2018 (for the United States), the number expected to be employed in 2026 (for states) or 2028 (for the United States), and rate of growth over those years.

    The projections are based on assumptions of unemployment rates and labor productivity growth rates.  While the projected numbers may not be exact, they are helpful to compare one career to another, or one location to another.

    What is the source of this information?

    State-level data come from Projections Central and each state's Labor Market Information office, 2016-26.

    National-level data come from the Bureau of Labor Statistics Employment Projections, 2018-28.

Typical wages

Annual wages for Compliance Officers* in United States
This graph displays wage data.  Find details by selecting the table view.
* You’re seeing wages for Compliance Officers because we don’t have information for Regulatory Affairs Specialists.
This chart displays wage data.  Find details by selecting the table view.
LocationUnited States
10%$38,320
25%$50,620
Median$68,860
75%$90,980
90%$109,650


    What does this information tell me?

    This chart shows you a range of how much most workers in this occupation earn per hour, in the location that you selected.

    You can select from three views of this data:

    • The Graph shows you wages at the 10th, 25th, 50th, 75th and 90th percentiles. Note that the lowest (10th %ile) wage shown is not necessarily a "starting wage." Instead it means that 10 percent of all workers in this career earn less that this amount, and 90 percent earn more. However, you can assume that you might earn close to the 10th or 25th %ile wages when you start out in most careers.
    • Select "Chart" to see a visual comparison between national wages and wages in the location you selected.
    • Select "Table" to see more wage data the national and local level.

    Please note that wage data are not available at the city or ZIP code level. If you selected a city or ZIP code, you will see wage data for the regional area.

    Also note that in this update, 21 detailed occupations found within the 2010 Standard Occupational Classification (SOC) were replaced with 10 new aggregations of those occupations; read more about these OES changes.

    You can learn more about wages for this and other occupations by clicking “See more wages” above.

    What is the source of this information?

    The wage information comes from the Bureau of Labor Statistics, Occupational Employment Statistics Program, 2018 data. For more detailed state wage data, please find the link to your state's wage data program in the Other Resources box.

Education and experience: to get started
People starting in this career usually have:
  • Bachelor's degree
  • No work experience
  • 1 to 12 months on-the-job training

You’re seeing education information for Compliance officers because we don’t have information for Regulatory Affairs Specialists. Please note the information may not be the same for both occupations.

    What does this information tell me?

    This shows you the typical level of education, work experience, and on-the-job training that most people have when they start in this career. Note that these are not requirements for entering this field, but the information can help you understand how qualified you might be.

    Interested in starting in this career? You can search for education programs in your local area by clicking “Find local training” above.

    What is the source of this information?

    This information comes from the U.S. Department of Labor's Bureau of Labor Statistics Employment Projections, Education and training assignments by detailed occupation, 2018.

Typical education
How much education do most people in this career have?
Chart. Percent of workers in this field by education level attained
You’re seeing education information for Compliance officers because we don’t have information for Regulatory Affairs Specialists. Please note the information may not be the same for both occupations.

    What does this information tell me?

    This chart shows you the range of education levels that people who currently work in this field have. You can use this to see if you fit in this range. Note that this includes ALL people who work in this field and not just those getting started.

    Interested in getting qualified for this career? You can search for programs that lead to the education needed, in your local area, by clicking “Find local training” above.

    What is the source of this information?

    This information comes from the Bureau of Labor Statistics Employment Projections, Educational attainment for workers 25 years and older by detailed occupation, 2016–17.

Certifications: show your skills
Let employers know you have the skills to do well at this job.
Earning a certification can help you:
  • Get a job
  • Get a promotion

    What does this information tell me?

    When you click "Find certifications" you'll see a list of national certifications that are related to this career. From there, you can learn how to achieve one of these certifications to help you enter or get ahead in this field.

    What is the source of this information?

    This collection of occupational certifications is collected and regularly updated by CareerOneStop. Learn more at Certification Finder Help.

Licenses: do you need one?
Some states require an occupational license to work in this career.

    What does this information tell me?

    When you click "Find license details in your state" you'll see the license name and contact information for the agency in your state that oversees licensing for this field. If you have not selected a location, you'll see a list of all state licenses for this occupation.

    What is the source of this information?

    Information on licensed occupations is gathered in each state by Labor Market Information units under a grant from the U.S. Department of Labor. Learn more at License Finder Help.

Apprenticeships: learn on the job
Apprenticeships combine paid on-the-job-training with classroom lessons.

    What does this information tell me?

    When you click "Find apprenticeship sponsors" you'll find information that can help you locate apprenticeship opportunities in your state:

    • If there are businesses that have sponsored apprenticeships in this field in the past, you'll find their name and contact information.
    • If there are related occupations that might have apprenticeship opportunities, you'll find links to that information.
    • You'll also see contact information for state and federal agencies that oversee apprenticeship programs.

    What is the source of this information?

    Apprenticeship information comes from the U.S. Department of Labor, Office of Apprenticeships, and from CareerOneStop. Learn more at Apprenticeship Finder Help.

Activities: what you might do in a day
  • 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.
  • Review documents or materials for compliance with policies or regulations.
  • Compile technical information or documentation.
  • Update knowledge of legal or regulatory environments.
  • Communicate with government agencies.
  • Examine financial records or processes.
  • Maintain data in information systems or databases.
  • Establish organizational guidelines or policies.
  • Prepare financial documents.
  • Analyze environmental regulations to ensure organizational compliance.
  • Monitor business indicators.
  • Train personnel in organizational or compliance procedures.
  • Recommend changes or corrective procedures.
  • Analyze data to identify or resolve operational problems.
  • Investigate system, equipment, or product failures.
  • Correspond with customers to answer questions or resolve complaints.

    What does this information tell me?

    This is a list of typical work activities that people in this career might do on the job. You can use this list to get an idea of whether this career might be a good fit for you.

    Click on “More activities” to see more detailed examples of activities for this career.

    You can also use this list to help you prepare for a job interview. Or, if you’ve already held a job like this, you can copy these activities to use on your resume.

    What is the source of this information?

    This information comes from O*NET OnLine's Occupation Information. They are O*NET’s Detailed Work Activities.

Knowledge
People in this career often know a lot about:
  • English Language - 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 - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
  • Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

    What does this information tell me?

    This is a list of general knowledge areas that are most commonly required for jobs in the career. Knowledge is typically gained through education and related experience.

    This list can help you learn if you are prepared for a job in this career. It can also help you decide on education or training programs that could help you prepare for the career.

    What is the source of this information?

    This information comes from the O*NET Resource Center. Learn more about O*NET's Knowledge descriptors.

Skills
People in this career often have these skills:
  • Writing - Writing things for co-workers or customers.
  • Speaking - Talking to others.
  • Active Listening - Listening to others, not interrupting, and asking good questions.
  • Critical Thinking - Thinking about the pros and cons of different ways to solve a problem.
  • Judgment and Decision Making - Thinking about the pros and cons of different options and picking the best one.
  • Reading Comprehension - Reading work-related information.
  • Systems Analysis - Figuring out how a system should work and how changes in the future will affect it.
  • Complex Problem Solving - Noticing a problem and figuring out the best way to solve it.
  • Social Perceptiveness - Understanding people's reactions.
  • Time Management - Managing your time and the time of other people.

    What does this information tell me?

    This is a list of a list the work-related skills most commonly required for jobs in the career.

    This list can help you understand how well your current skills fit this career. It can also help you plan your education or professional development.

    What is the source of this information?

    This information comes from the O*NET Resource Center. Learn more about O*NET's Skills descriptors.

Abilities
People in this career often have talent in:
  • Written Comprehension - Reading and understanding what is written.
  • Written Expression - Communicating by writing.
  • Oral Expression - Communicating by speaking.
  • Oral Comprehension - Listening and understanding what people say.
  • Deductive Reasoning - Using rules to solve problems.
  • Inductive Reasoning - Making general rules or coming up with answers from lots of detailed information.
  • Problem Sensitivity - Noticing when problems happen.
  • Speech Clarity - Speaking clearly.
  • Speech Recognition - Recognizing spoken words.
  • Near Vision - Seeing details up close.
  • Information Ordering - Ordering or arranging things.

    What does this information tell me?

    This is a list of a list of personal qualities that might influence work and are most commonly required for success in this career.

    This list can help you understand if your natural strengths and abilities are a good fit for this career.

    What is the source of this information?

    This information comes from the O*NET Resource Center. Learn more about O*NET's Abilities descriptors.

Interests
  • Conventional - Occupations related to Conventional interests frequently involve following set procedures and routines. They include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
  • Enterprising - Occupations with Enterprising interests frequently involve starting up and carrying out projects. Many involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.

    What does this information tell me?

    This is a list of work environment-preferences that are most commonly associated with the career. It can help you understand if your natural interests are a good fit for this career.

    Click "Take an interest assessment" for a quick 30-question assessment that can help you understand your interests and see careers that might be good matches for them.

    What is the source of this information?

    This information comes from the O*NET Resource Center. Learn more about O*NET's Interest descriptors.

Typical tasks
  • 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.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • 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.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
  • 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.
  • 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.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Monitor national or international legislation on ozone-depleting substances or global warming.

    What does this information tell me?

    This is a list of typical tasks that people in this career might do on the job.  You can use this list to get an idea of whether this career might be a good fit for you.

    Click on “More tasks” to see more detailed examples for this career.

    You can also use this list to help you prepare for a job interview. Or, if you’ve already held a job like this, you can copy these tasks to use on your resume.

    What is the source of this information?

    This information comes from O*NET OnLine's Occupation Information. They are O*NET‘s Tasks.

Other resources

    What does this information tell me?

    These are additional online resources related to this career. You may find different or more detailed information at these sources.

    What is the source of this information?

    This information is collected and maintained by CareerOneStop.