Regulatory Affairs Managers
Overview
SaveJob 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, conservation scientists, art directors, and cost estimators.
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Demand
Core 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.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Participate in the development or implementation of clinical trial protocols.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- 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.
- Develop and maintain standard operating procedures or local working practices.
- Train staff in regulatory policies or procedures.
- 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.
Technology Skills
Technology
Example
Hot Technology
Tools Used
Tool
Example
Top 10 Knowledge Required
English Language
92%
Knowledge of the structure and content of the English language including the meaning and spelling of words, and rules of composition and grammar.
Law and Government
80%
Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Administration and Management
74%
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
68%
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Education and Training
62%
Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Administrative
61%
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
61%
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.
Computers and Electronics
59%
Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
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.
Mathematics
55%
Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Top 10 Skills
Writing
85%
Communicating effectively in writing as appropriate for the needs of the audience.
Reading Comprehension
83%
Understanding written sentences and paragraphs in work-related documents.
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.
Critical Thinking
78%
Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Complex Problem Solving
75%
Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Judgment and Decision Making
75%
Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Systems Analysis
75%
Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Systems Evaluation
75%
Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.
Monitoring
73%
Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Top 10 Abilities
Written Expression
85%
The ability to communicate information and ideas in writing so others will understand.
Oral Comprehension
83%
The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression
83%
The ability to communicate information and ideas in speaking so others will understand.
Written Comprehension
83%
The ability to read and understand information and ideas presented in writing.
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).
Near Vision
75%
The ability to see details at close range (within a few feet of the observer).
Problem Sensitivity
75%
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
75%
The ability to speak clearly so others can understand you.
Speech Recognition
75%
The ability to identify and understand the speech of another person.
Top 10 Work Activities
Evaluating Information to Determine Compliance with Standards
94%
Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
Communicating with People Outside the Organization
93%
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
93%
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
93%
Translating or explaining what information means and how it can be used.
Getting Information
91%
Observing, receiving, and otherwise obtaining information from all relevant sources.
Making Decisions and Solving Problems
90%
Analyzing information and evaluating results to choose the best solution and solve problems.
Updating and Using Relevant Knowledge
89%
Keeping up-to-date technically and applying new knowledge to your job.
Working with Computers
87%
Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Documenting/Recording Information
86%
Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
Identifying Objects, Actions, and Events
86%
Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
Detailed Work Activities
- Develop operating strategies, plans, or procedures.
- Review documents or materials for compliance with policies or regulations.
- Manage control system activities in organizations.
- Prepare reports related to compliance matters.
- Maintain regulatory or compliance documentation.
- Coordinate with external parties to exchange information.
- Represent the organization in external relations.
- Advise others on legal or regulatory compliance matters.
- Communicate organizational policies and procedures.
- Maintain knowledge of current developments in area of expertise.
- Implement organizational process or policy changes.
- Develop organizational policies or programs.
- Coordinate regulatory documentation activities.
- Manage documentation to ensure organization or accuracy.
- Examine marketing materials to ensure compliance with policies or regulations.
- Develop organizational methods or procedures.
- Monitor organizational procedures to ensure proper functioning.
- Develop organizational goals or objectives.
- Prepare operational budgets.
- Prepare staff schedules or work assignments.
- Conduct employee training programs.
- Monitor organizational compliance with regulations.
- Confer with organizational members to accomplish work activities.
- Monitor external affairs or events affecting business operations.
- Establish interpersonal business relationships to facilitate work activities.
- Evaluate environmental impact of operational or development activities.
- Evaluate potential of products, technologies, or resources.
- Coordinate operational activities with external stakeholders.
Education
Interests
Enterprising
92%
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
87%
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.
Investigative
41%
Work involves studying and researching non-living objects, living organisms, disease or other forms of impairment, or human behavior. Investigative occupations are often associated with physical, life, medical, or social sciences, and can be found in the fields of humanities, mathematics/statistics, information technology, or health care service.
Social
38%
Work involves helping, teaching, advising, assisting, or providing service to others. Social occupations are often associated with social, health care, personal service, teaching/education, or religious activities.
Realistic
25%
Work involves designing, building, or repairing of equipment, materials, or structures, engaging in physical activity, or working outdoors. Realistic occupations are often associated with engineering, mechanics and electronics, construction, woodworking, transportation, machine operation, agriculture, animal services, physical or manual labor, athletics, or protective services.
Artistic
18%
Work involves creating original visual artwork, performances, written works, food, or music for a variety of media, or applying artistic principles to the design of various objects and materials. Artistic occupations are often associated with visual arts, applied arts and design, performing arts, music, creative writing, media, or culinary art.
Work Values
Achievement
72%
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%
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%
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%
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%
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%
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.
Colleges
SAGE Scholars Member Schools that offer majors leading to this career.
Check out the College Search to see the full list of schools with majors for this career.