Regulatory Affairs Managers

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

Sample of reported job titles: Global Regulatory Affairs Director (Global RA Director), Global Regulatory Affairs Manager (Global RA Manager), Regulatory Affairs Director (RA Director), Regulatory Affairs Manager (RA Manager), Regulatory Affairs Quality Assurance Director (RA QA Director), Regulatory Director, Regulatory Science Director

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Tasks

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

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Technology Skills

All 21 displayed Show 7 tools used

Analytical or scientific software — Analyse-it; Statistical analysis software
Business intelligence and data analysis software — Tableau
Cloud-based data access and sharing software — Microsoft SharePoint
Compliance software — Aris Global Register; MediRegs E-dition Compliance Monitor; SAP EHS Management; Thomson Reuters Liquent InSight Suite (see all 9 examples)
Data base user interface and query software — Database software ; Microsoft Access ; Structured query language SQL
Desktop publishing software — Document publishing software
Development environment software — Integrated development environment IDE software ; Software development tools
Document management software — Adlib Express; Adobe Systems Adobe Acrobat ; Axway eSubmissions; Virtify eCTD (see all 32 examples)
Electronic mail software — IBM Notes ; Microsoft Outlook
Enterprise application integration software — XML authoring software
Enterprise resource planning ERP software — SAP
Information retrieval or search software — Dialog DialogLink
Internet browser software — Web browser software
Office suite software — Microsoft Office
Operating system software — Microsoft Windows
Presentation software — Microsoft PowerPoint
Process mapping and design software — Microsoft Visio
Project management software — Microsoft Project ; Total quality management TQM software
Risk management data and analysis software — MasterControl software; Risk management software
Spreadsheet software — Microsoft Excel
Word processing software — Microsoft Word

Hot Technology — a technology requirement frequently included in employer job postings.

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Knowledge

All 8 displayed

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.
Medicine and Dentistry — 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.
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.
Computers and Electronics — Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

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Skills

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Reading Comprehension — Understanding written sentences and paragraphs in work-related documents.
Speaking — Talking to others to convey information effectively.
Writing — Communicating effectively in writing as appropriate for the needs of the audience.
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.
Coordination — Adjusting actions in relation to others’ actions.
Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Monitoring — Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
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.
Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
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.
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.
Management of Personnel Resources — Motivating, developing, and directing people as they work, identifying the best people for the job.
Social Perceptiveness — Being aware of others’ reactions and understanding why they react as they do.
Instructing — Teaching others how to do something.
Negotiation — Bringing others together and trying to reconcile differences.
Persuasion — Persuading others to change their minds or behavior.
Learning Strategies — Selecting and using training/instructional methods and procedures appropriate for the situation when learning or teaching new things.
Operations Analysis — Analyzing needs and product requirements to create a design.

Abilities

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Written Comprehension — The ability to read and understand information and ideas presented in writing.
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 Expression — The ability to communicate information and ideas in writing so others will understand.
Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
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.
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).
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).
Speech Recognition — The ability to identify and understand the speech of another person.
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.

Work Activities

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

Detailed Work Activities

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Coordinate with external parties to exchange information.
Manage control system activities in organizations.
Review documents or materials for compliance with policies or regulations.
Develop operating strategies, plans, or procedures.
Implement organizational process or policy changes.
Develop organizational policies or programs.
Maintain knowledge of current developments in area of expertise.
Examine marketing materials to ensure compliance with policies or regulations.
Communicate organizational policies and procedures.
Advise others on legal or regulatory compliance matters.
Monitor external affairs or events affecting business operations.
Coordinate regulatory documentation activities.
Manage documentation to ensure organization or accuracy.
Maintain regulatory or compliance documentation.
Prepare reports related to compliance matters.
Conduct employee training programs.
Represent the organization in external relations.
Develop organizational methods or procedures.
Monitor organizational procedures to ensure proper functioning.
Confer with organizational members to accomplish work activities.
Establish interpersonal business relationships to facilitate work activities.
Develop organizational goals or objectives.
Prepare operational budgets.
Prepare staff schedules or work assignments.
Coordinate operational activities with external stakeholders.
Evaluate potential of products, technologies, or resources.
Monitor organizational compliance with regulations.
Evaluate environmental impact of operational or development activities.

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Work Context

All 22 displayed

Electronic Mail — 100% responded “Every day.”
Telephone — 93% responded “Every day.”
Face-to-Face Discussions — 85% responded “Every day.”
Indoors, Environmentally Controlled — 93% responded “Every day.”
Spend Time Sitting — 82% responded “Continually or almost continually.”
Duration of Typical Work Week — 82% responded “More than 40 hours.”
Importance of Being Exact or Accurate — 61% responded “Extremely important.”
Work With Work Group or Team — 58% responded “Extremely important.”
Contact With Others — 48% responded “Constant contact with others.”
Freedom to Make Decisions — 46% responded “Some freedom.”
Impact of Decisions on Co-workers or Company Results — 39% responded “Very important results.”
Coordinate or Lead Others — 37% responded “Extremely important.”
Time Pressure — 50% responded “Once a week or more but not every day.”
Letters and Memos — 41% responded “Once a week or more but not every day.”
Structured versus Unstructured Work — 54% responded “Some freedom.”
Responsibility for Outcomes and Results — 48% responded “High responsibility.”
Deal With External Customers — 30% responded “Very important.”
Frequency of Conflict Situations — 43% responded “Once a week or more but not every day.”
Frequency of Decision Making — 48% responded “Once a month or more but not every week.”
Level of Competition — 50% responded “Moderately competitive.”
Consequence of Error — 30% responded “Extremely serious.”
Importance of Repeating Same Tasks — 29% responded “Important.”

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, chemists, art directors, and cost estimators.
SVP Range	(7.0 to < 8.0)

Education

Percentage of Respondents	Education Level Required
75	Bachelor’s degree
14	Master’s degree
4	Associate’s degree

Credentials

Interests

All 2 displayed

Interest code: EC Want to discover your interests? Take the O*NET Interest Profiler at My Next Move.

Enterprising — 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.
Conventional — 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.

Work Styles

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Integrity — Job requires being honest and ethical.
Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high-stress situations.
Leadership — Job requires a willingness to lead, take charge, and offer opinions and direction.
Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems.
Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
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.
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.
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.

Work Values

All 3 displayed

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.

Related Occupations

All 10 displayed

11-3071.00	Transportation, Storage, and Distribution Managers
11-3111.00	Compensation and Benefits Managers
11-3121.00	Human Resources Managers
11-9121.01	Clinical Research Coordinators
13-1041.07	Regulatory Affairs Specialists
13-1071.00	Human Resources Specialists
13-1111.00	Management Analysts Bright Outlook
13-1151.00	Training and Development Specialists
13-2011.00	Accountants and Auditors
13-2099.04	Fraud Examiners, Investigators and Analysts

Wages & Employment Trends

Median wage data for Personal Service Managers, All Other; Entertainment and Recreation Managers, Except Gambling; and Managers, All Other.
Employment data for Personal Service Managers, All Other; Entertainment and Recreation Managers, Except Gambling; and Managers, All Other.
Industry data for Personal Service Managers, All Other; Entertainment and Recreation Managers, Except Gambling; and Managers, All Other.

Median wages (2020)	$55.94 hourly, $116,350 annual
State wages
Local wages	ZIP Code:

Employment (2020)	573,000 employees
Projected growth (2020-2030)	Average (5% to 10%)
Projected job openings (2020-2030)	47,100
State trends

Top industries (2020)	Government Professional, Scientific, and Technical Services

Source: Bureau of Labor Statistics 2020 wage data external site and 2020-2030 employment projections . “Projected growth” represents the estimated change in total employment over the projections period (2020-2030). “Projected job openings” represent openings due to growth and replacement.

Job Openings on the Web

Sources of Additional Information

All 9 displayed

Disclaimer: Sources are listed to provide additional information on related jobs, specialties, and/or industries. Links to non-DOL Internet sites are provided for your convenience and do not constitute an endorsement.

American Chemical Society
American Society for Quality
DIA
International Society for Pharmaceutical Engineering
North Carolina Regulatory Affairs Forum
Orange County Regulatory Affairs Discussion Group
Parenteral Drug Association
Regulatory Affairs Professionals Society
Society of Quality Assurance

This page includes information from O*NET OnLine 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.