Regulatory Affairs Managers

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.

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

Demand
Career Demand by State Career Demand by State Legend
Core Tasks

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.

Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

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.

Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

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.

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 procedures or systems for publishing document submissions in hardcopy or electronic formats.

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.

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.

Technology Skills
Technology
Example
Hot Technology
Analytical or scientific software
Risk management software
Business intelligence and data analysis software
Tableau
Compliance software
Pilgrim Regulatory Submission
Data base user interface and query software
Microsoft Access
Desktop publishing software
Document publishing software
Development environment software
Integrated development environment IDE software
Document management software
Adobe Systems Adobe Acrobat
Electronic mail software
IBM Notes
Enterprise application integration software
XML authoring software
Enterprise resource planning ERP software
SAP
Graphics or photo imaging software
Microsoft Visio
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
Project management software
Microsoft SharePoint
Spreadsheet software
Microsoft Excel
Word processing software
Microsoft Word
Tools Used
Tool
Example
Communications Devices and Accessories
Multi-line telephone systems
Computer Equipment and Accessories
Laptop computers
Office machines and their supplies and accessories
Photocopying equipment
Top 10 Knowledge Required
English Language
85%
Importance

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
81%
Importance

Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

Administration and Management
74%
Importance

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
66%
Importance

Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

Medicine and Dentistry
64%
Importance

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
63%
Importance

Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.

Clerical
60%
Importance

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.

Computers and Electronics
60%
Importance

Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.

Production and Processing
60%
Importance

Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.

Chemistry
58%
Importance

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.

Top 10 Skills
Reading Comprehension
80%
Importance

Understanding written sentences and paragraphs in work related documents.

Speaking
80%
Importance

Talking to others to convey information effectively.

Writing
80%
Importance

Communicating effectively in writing as appropriate for the needs of the audience.

Active Listening
78%
Importance

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
78%
Importance

Adjusting actions in relation to others' actions.

Critical Thinking
78%
Importance

Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Monitoring
78%
Importance

Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

Judgment and Decision Making
75%
Importance

Considering the relative costs and benefits of potential actions to choose the most appropriate one.

Systems Analysis
73%
Importance

Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.

Complex Problem Solving
70%
Importance

Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.

Top 10 Abilities
Written Comprehension
83%
Importance

The ability to read and understand information and ideas presented in writing.

Oral Comprehension
80%
Importance

The ability to listen to and understand information and ideas presented through spoken words and sentences.

Oral Expression
80%
Importance

The ability to communicate information and ideas in speaking so others will understand.

Written Expression
80%
Importance

The ability to communicate information and ideas in writing so others will understand.

Deductive Reasoning
78%
Importance

The ability to apply general rules to specific problems to produce answers that make sense.

Problem Sensitivity
78%
Importance

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%
Importance

The ability to speak clearly so others can understand you.

Inductive Reasoning
75%
Importance

The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).

Near Vision
75%
Importance

The ability to see details at close range (within a few feet of the observer).

Information Ordering
73%
Importance

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
Getting Information
95%
Importance

Observing, receiving, and otherwise obtaining information from all relevant sources.

Evaluating Information to Determine Compliance with Standards
93%
Importance

Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

Making Decisions and Solving Problems
92%
Importance

Analyzing information and evaluating results to choose the best solution and solve problems.

Updating and Using Relevant Knowledge
92%
Importance

Keeping up-to-date technically and applying new knowledge to your job.

Communicating with Supervisors, Peers, or Subordinates
90%
Importance

Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Communicating with Persons Outside Organization
89%
Importance

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.

Documenting/Recording Information
89%
Importance

Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Interpreting the Meaning of Information for Others
87%
Importance

Translating or explaining what information means and how it can be used.

Analyzing Data or Information
86%
Importance

Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Processing Information
85%
Importance

Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Detailed Work Activities

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.

Coordinate regulatory documentation activities.

Manage documentation to ensure organization or accuracy.

Monitor external affairs or events affecting business operations.

Prepare reports related to compliance matters.

Maintain regulatory or compliance documentation.

Represent the organization in external relations.

Conduct employee training programs.

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.

Evaluate potential of products, technologies, or resources.

Coordinate operational activities with external stakeholders.

Monitor organizational compliance with regulations.

Evaluate environmental impact of operational or development activities.

Work Context
Electronic Mail

How often do you use electronic mail in this job?

Indoors, Environmentally Controlled

How often does this job require working indoors in environmentally controlled conditions?

Telephone

How often do you have telephone conversations in this job?

Face-to-Face Discussions

How often do you have to have face-to-face discussions with individuals or teams in this job?

Spend Time Sitting

How much does this job require sitting?

Importance of Being Exact or Accurate

How important is being very exact or highly accurate in performing this job?

Work With Work Group or Team

How important is it to work with others in a group or team 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?

Impact of Decisions on Co-workers or Company Results

What results do your decisions usually have on other people or the image or reputation or financial resources of your employer?

Coordinate or Lead Others

How important is it to coordinate or lead others in accomplishing work activities in this job?

Education
Majors   based on the broader career Managers, All Other
Major
Radio, Television, and Digital Communication
Computer/Information Technology Administration and Management
Library Science and Administration
Systems Science and Theory
Historic Preservation and Conservation
Economics and Computer Science
Economics and Foreign Language/Literature
Geoarcheaology
History and Language/Literature
History and Political Science
Linguistics and Anthropology
Philosophy, Politics, and Economics
Digital Humanities and Textual Studies
Religious Institution Administration and Law
Psychology, General
Research and Experimental Psychology
Clinical, Counseling and Applied Psychology
Psychology, Other
Criminal Justice and Corrections
Fire Protection
Homeland Security
Security Science and Technology
Public Administration
Social Sciences, General
Anthropology
Archeology
Criminology
Demography
Economics
Geography and Cartography
International Relations and National Security Studies
Political Science and Government
Sociology
Urban Studies/Affairs
Sociology and Anthropology
Geography and Anthropology
Social Sciences, Other
Arts, Entertainment, and Media Management
Health and Medical Administrative Services
Pharmacy, Pharmaceutical Sciences, and Administration
Business/Commerce, General
Business Administration, Management and Operations
Entrepreneurial and Small Business Operations
Hospitality Administration/Management
Telecommunications Management
History
Interests
Enterprising
100%
Importance

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
77%
Importance

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.

Social
48%
Importance

Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.

Investigative
29%
Importance

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.

Artistic
24%
Importance

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.

Realistic
24%
Importance

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.

Top 10 Work Styles
Integrity
98%
Importance

Job requires being honest and ethical.

Attention to Detail
96%
Importance

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

Dependability
90%
Importance

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

Stress Tolerance
88%
Importance

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

Leadership
87%
Importance

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

Analytical Thinking
85%
Importance

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

Cooperation
85%
Importance

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

Adaptability/Flexibility
84%
Importance

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

Initiative
84%
Importance

Job requires a willingness to take on responsibilities and challenges.

Persistence
82%
Importance

Job requires persistence in the face of obstacles.

Work Values
Achievement
72%
Importance

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
72%
Importance

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

Support
67%
Importance

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

Working Conditions
67%
Importance

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
62%
Importance

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
62%
Importance

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.