Regulatory Affairs Managers
11-9199.01
Bright Outlook Updated 2024

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Sample of reported job titles: CMC Director (Chemistry, Manufacturing, and Controls Director); Compliance Director; Global RA Director (Global Regulatory Affairs Director); Global RA Manager (Global Regulatory Affairs Manager); RA Director (Regulatory Affairs Director); RA Manager (Regulatory Affairs Manager); RA QA Director (Regulatory Affairs Quality Assurance Director); RA VP (Regulatory Affairs Vice President); Regulatory Director; Vaccine RA Director (Vaccine Regulatory Affairs Director)

Occupation-Specific Information

Tasks

  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Participate in the development or implementation of clinical trial protocols.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Train staff in regulatory policies or procedures.
  • Develop and maintain standard operating procedures or local working practices.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Monitor regulatory affairs trends related to environmental issues.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
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Technology Skills

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In demand
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Occupational Requirements

Work Activities

  • Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
  • Communicating with People Outside the Organization — 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.
  • Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
  • Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
  • Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
  • Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
  • Working with Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
  • Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
  • Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
  • Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
  • Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
  • Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.
  • Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Providing Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
  • Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
  • Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.
  • Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
  • Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
  • Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
  • Guiding, Directing, and Motivating Subordinates — Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
  • Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.
  • Monitoring Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
  • Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.
  • Judging the Qualities of Objects, Services, or People — Assessing the value, importance, or quality of things or people.
  • Estimating the Quantifiable Characteristics of Products, Events, or Information — Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
  • Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
  • Selling or Influencing Others — Convincing others to buy merchandise/goods or to otherwise change their minds or actions.

Detailed Work Activities

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Work Context

Experience Requirements

Job Zone

Title
Job Zone Four: Considerable Preparation Needed
Education
Most of these occupations require a four-year bachelor's degree, but some do not.
Related 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.
Job Training
Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Job Zone Examples
Many of these occupations involve coordinating, supervising, managing, or training others. Examples include real estate brokers, sales managers, database administrators, graphic designers, conservation scientists, art directors, and cost estimators.
SVP Range
(7.0 to < 8.0)

Training & Credentials

State training
Local training
Certifications
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Apprenticeship Opportunities

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Worker Requirements

Skills

  • Writing — Communicating effectively in writing as appropriate for the needs of the audience.
  • Reading Comprehension — Understanding written sentences and paragraphs in work-related documents.
  • Active Listening — 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 — Talking to others to convey information effectively.
  • Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
  • Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
  • Systems Evaluation — Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
  • Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
  • Time Management — Managing one's own time and the time of others.
  • Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
  • Coordination — Adjusting actions in relation to others' actions.
  • Instructing — Teaching others how to do something.
  • Social Perceptiveness — Being aware of others' reactions and understanding why they react as they do.
  • Learning Strategies — Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
  • Management of Personnel Resources — Motivating, developing, and directing people as they work, identifying the best people for the job.
  • Negotiation — Bringing others together and trying to reconcile differences.
  • Persuasion — Persuading others to change their minds or behavior.

Knowledge

  • 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.
  • Administration and Management — 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.
  • Biology — Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
  • Education and Training — Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
  • Administrative — Knowledge of administrative and office procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and workplace terminology.
  • Chemistry — 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.

Education

How much education does a new hire need to perform a job in this occupation? Respondents said:

  • 74%
     
    Bachelor’s degree required
  • 13%
     
    Master’s degree required
  • 4%
     
    Some college, no degree required

Worker Characteristics

Abilities

  • Written Expression — The ability to communicate information and ideas in writing so others will understand.
  • Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
  • Written Comprehension — The ability to read and understand information and ideas presented in writing.
  • Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
  • Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
  • Near Vision — The ability to see details at close range (within a few feet of the observer).
  • Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing that there is a problem.
  • Speech Clarity — The ability to speak clearly so others can understand you.
  • Speech Recognition — The ability to identify and understand the speech of another person.
  • Information Ordering — 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).
  • Fluency of Ideas — The ability to come up with a number of ideas about a topic (the number of ideas is important, not their quality, correctness, or creativity).
  • Category Flexibility — The ability to generate or use different sets of rules for combining or grouping things in different ways.
  • Originality — The ability to come up with unusual or clever ideas about a given topic or situation, or to develop creative ways to solve a problem.

Interests

Interest code: EC
Want to discover your interests? Take the O*NET Interest Profiler at My Next Move.
  • Enterprising — Work involves managing, negotiating, marketing, or selling, typically in a business setting, or leading or advising people in political and legal situations. Enterprising occupations are often associated with business initiatives, sales, marketing/advertising, finance, management/administration, professional advising, public speaking, politics, or law.
  • Conventional — Work involves following procedures and regulations to organize information or data, typically in a business setting. Conventional occupations are often associated with office work, accounting, mathematics/statistics, information technology, finance, or human resources.

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

Work Styles

  • Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
  • Integrity — Job requires being honest and ethical.
  • Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.
  • Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
  • Initiative — Job requires a willingness to take on responsibilities and challenges.
  • Persistence — Job requires persistence in the face of obstacles.
  • Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
  • Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high-stress situations.
  • Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems.
  • Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction.
  • Self-Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
  • Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering 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.

Workforce Characteristics

Wages & Employment Trends

Median wage data for Managers, All Other.
Employment data for Managers, All Other.
Industry data for Managers, All Other.
Median wages (2023)
$64.21 hourly, $133,560 annual
State wages
Local wages
Employment (2023)
1,282,500 employees
Projected growth (2023-2033)
Faster than average (6% to 8%)
Projected job openings (2023-2033)
105,800
State trends
Top industries (2023)

Source: Bureau of Labor Statistics 2023 wage data and 2023-2033 employment projections . “Projected growth” represents the estimated change in total employment over the projections period (2023-2033). “Projected job openings” represent openings due to growth and replacement.

Job Openings on the Web

State job openings
Local job openings

More Information

Professional Associations

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National Associations